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Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)

Primary Purpose

Menorrhagia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Intrauterine Ultrasound-Guided Radiofreq. Ablation System

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Abnormal Uterine Bleeding associated with fibroids, AUB-L, Fibroids, Heavy menstrual bleeding, HMB, Myoma, Menorrhagia

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

premenopausal
≥ 25 and ≤ 50 years of age at time of enrollment
experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months
between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm
at least one type 1, type 2, type 3, or type 2-5 fibroid.
PBAC score ≥ 150 and ≤ 500
consistent menstrual cycles
not at material risk for pregnancy
speaks and reads a language for which validated questionnaires are available
willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements

Exclusion Criteria:

pregnancy
urgent need for surgery to treat fibroid symptoms
desire for current or future childbearing
presence of a tubal implant for sterilization
postmenopausal by history
presence of type 0 fibroids, unless < 1 cm in diameter
presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size
any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm
bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
exclusive presence of fibroids that are insufficient to explain the severity of symptoms
presence of clinically relevant fibroids that cannot be treated for technical reasons
presence of an extrauterine pelvic mass that has not been diagnosed as benign
IUD/IUS in situ within the washout period
previous procedure for fibroids or heavy menstrual bleeding other than myomectomy
myomectomy within 12 months
any abnormality of the endometrial cavity that obstructs access of the handpiece
contraindication to MRI
total uterine volume > 1000 cc
clinically significant adenomyosis
confirmed or suspected diagnosis of clinically relevant endometriosis
one or more clinically relevant fibroids that are significantly calcified.
previous pelvic irradiation
renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]
evidence of disorders of hemostasis (AUB-C)
abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia
confirmed abdominal / pelvic malignancy within the previous five years
active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;
use of a hormonally-relevant medication within the washout period
use of an antifibrinolytic agent while undergoing any screening procedures
current use of anticoagulant therapy
chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain
chronic uncontrolled moderate and severe hypertension
hypoplastic or otherwise short uterus
major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data
any other reason for which the individual study subject is not appropriate or suitable for participation

Sites / Locations

Kelly H. Roy M.D. P.C.
Advanced Women's Health Institute
Christiana Care Health Services, Inc.
George Washington University Hospital
KO Clinical Research, LLC
Visions Clinical Research
The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates
University of Maryland Medical Center
Wayne State University
University of Mississippi Medical Center
Mercy Clinic, Minimally Invasive Gynecology
Cooper University Hospital
Basque Women's Care
Montefiore Medical Center
Carolina Women's Research and Wellness Center
Drexel University
Magee Women's Hospital
Greenville Health System
Baylor Research Institute
Willowbend Health and Wellness Associates
Eastern Virginia Medical School
Virginia Mason Medical Center
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects Treated with Sonata

Arm Description

Intervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with Sonata.

Outcomes

Primary Outcome Measures

Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)

The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.

Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure

This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.

Secondary Outcome Measures

Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)

Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.

Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months

The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.

Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months

The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.

Time to Return to Normal Activity (RTNA) in Days

Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.

Overall Treatment Effect (OTE) at 12 Months

The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.

Subject Satisfaction With Treatment at 12 Months

Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: "very satisfied", "moderately satisfied", "somewhat satisfied", "somewhat dissatisfied", "moderately dissatisfied", and "very dissatisfied".

Subject Willingness to Recommend Procedure at 12 Months

Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: "definitely yes", "probably yes", "probably no", and "definitely no".

Change in General Health State at 12 Months

Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.

Subject Pain

Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).

Procedure Tolerance

Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".

Mean Length of Stay

Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.

Occurrence of Pregnancy

Subjects were asked about the possible occurrence of pregnancy.

Pregnancy Outcome - Gestation Age

If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.

Pregnancy Outcome - Birth Weight

If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.

Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months

The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.

Full Information

NCT ID

NCT02228174

First Posted

August 25, 2014

Last Updated

February 3, 2020

Sponsor

Gynesonics

1. Study Identification

Unique Protocol Identification Number

NCT02228174

Brief Title

Sonography Guided Transcervical Ablation of Uterine Fibroids

Acronym

SONATA

Official Title

Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 18, 2017 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gynesonics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

Detailed Description

In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menorrhagia

Keywords

Abnormal Uterine Bleeding associated with fibroids, AUB-L, Fibroids, Heavy menstrual bleeding, HMB, Myoma, Menorrhagia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects Treated with Sonata

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Intrauterine Ultrasound-Guided Radiofreq. Ablation System

Other Intervention Name(s)

Gynesonics Sonata System

Intervention Description

The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).

Primary Outcome Measure Information:

Title

Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)

Description

Time Frame

Baseline and 12 Months

Title

Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure

Description

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)

Description

Time Frame

Each Follow-up Visit through 24 Months

Title

Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months

Description

The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.

Time Frame

Baseline and 12 Months

Title

Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months

Description

Time Frame

Baseline and 12 Months

Title

Time to Return to Normal Activity (RTNA) in Days

Description

Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.

Time Frame

30 Day post-procedure

Title

Overall Treatment Effect (OTE) at 12 Months

Description

The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.

Time Frame

12 Months

Title

Subject Satisfaction With Treatment at 12 Months

Description

Time Frame

12 Months

Title

Subject Willingness to Recommend Procedure at 12 Months

Description

Time Frame

12 Months

Title

Change in General Health State at 12 Months

Description

Time Frame

Baseline and 12 Months

Title

Subject Pain

Description

Time Frame

Immediately Post-procedure as well as Pre-discharge (Day 0)

Title

Procedure Tolerance

Description

Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".

Time Frame

Post-procedure (Day 0)

Title

Mean Length of Stay

Description

Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.

Time Frame

Day 0 - Day of Treatment

Title

Occurrence of Pregnancy

Description

Subjects were asked about the possible occurrence of pregnancy.

Time Frame

All Follow-up Visits through 24 Months

Title

Pregnancy Outcome - Gestation Age

Description

If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.

Time Frame

24 Months

Title

Pregnancy Outcome - Birth Weight

Description

If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.

Time Frame

24 Months

Title

Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months

Description

Time Frame

Baseline and 12 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: premenopausal ≥ 25 and ≤ 50 years of age at time of enrollment experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm at least one type 1, type 2, type 3, or type 2-5 fibroid. PBAC score ≥ 150 and ≤ 500 consistent menstrual cycles not at material risk for pregnancy speaks and reads a language for which validated questionnaires are available willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements Exclusion Criteria: pregnancy urgent need for surgery to treat fibroid symptoms desire for current or future childbearing presence of a tubal implant for sterilization postmenopausal by history presence of type 0 fibroids, unless < 1 cm in diameter presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7 exclusive presence of fibroids that are insufficient to explain the severity of symptoms presence of clinically relevant fibroids that cannot be treated for technical reasons presence of an extrauterine pelvic mass that has not been diagnosed as benign IUD/IUS in situ within the washout period previous procedure for fibroids or heavy menstrual bleeding other than myomectomy myomectomy within 12 months any abnormality of the endometrial cavity that obstructs access of the handpiece contraindication to MRI total uterine volume > 1000 cc clinically significant adenomyosis confirmed or suspected diagnosis of clinically relevant endometriosis one or more clinically relevant fibroids that are significantly calcified. previous pelvic irradiation renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)] evidence of disorders of hemostasis (AUB-C) abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia confirmed abdominal / pelvic malignancy within the previous five years active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia; use of a hormonally-relevant medication within the washout period use of an antifibrinolytic agent while undergoing any screening procedures current use of anticoagulant therapy chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain chronic uncontrolled moderate and severe hypertension hypoplastic or otherwise short uterus major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data any other reason for which the individual study subject is not appropriate or suitable for participation

Facility Information:

Facility Name

Kelly H. Roy M.D. P.C.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Advanced Women's Health Institute

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Christiana Care Health Services, Inc.

City

Newark

State/Province

Delaware

ZIP/Postal Code

19718

Country

United States

Facility Name

George Washington University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

KO Clinical Research, LLC

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Visions Clinical Research

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

Facility Name

University of Maryland Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Wayne State University

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Mercy Clinic, Minimally Invasive Gynecology

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Cooper University Hospital

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

Basque Women's Care

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Montefiore Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Carolina Women's Research and Wellness Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

Drexel University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Magee Women's Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Greenville Health System

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Baylor Research Institute

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Willowbend Health and Wellness Associates

City

Frisco

State/Province

Texas

ZIP/Postal Code

75035

Country

United States

Facility Name

Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León

City

Monterrey

State/Province

N.l.

ZIP/Postal Code

64460

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

35785107

Citation

Christoffel L, Bends R, Toub D, Schiermeier S, Pschadka G, Engelhardt M, Quinn S, Hartmann M, Habiba M, Felberbaum R, Brossner A, Schippert C, Romer T. Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System. J Gynecol Surg. 2022 Jun 1;38(3):207-213. doi: 10.1089/gyn.2021.0136. Epub 2022 Jun 13.

Results Reference

derived

PubMed Identifier

35497488

Citation

Roy K, Robinson JK. Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years. J Gynecol Surg. 2022 Apr 1;38(2):143-147. doi: 10.1089/gyn.2021.0073. Epub 2022 Apr 1.

Results Reference

derived

PubMed Identifier

33544889

Citation

Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.

Results Reference

derived

PubMed Identifier

30531573

Citation

Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019 Jan;133(1):13-22. doi: 10.1097/AOG.0000000000003032.

Results Reference

derived

Learn more about this trial

Sonography Guided Transcervical Ablation of Uterine Fibroids

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