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Fibroid Ablation Study (FAST-EU)

Primary Purpose

Leiomyoma, Uterine Fibroids, Menorrhagia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VizAblate System
Sponsored by
Gynesonics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring uterine fibroid RF ablation, intrauterine ultrasound, VizAblate

Eligibility Criteria

28 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 28 years of age or older
  • Regular, consistent menstrual cycles
  • History of excessive bleeding
  • One Menstrual Pictogram score ≥ 120 during a one-month screening period
  • Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
  • Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc
  • At least one fibroid must indent the endometrium
  • Subject is not at material risk for pregnancy.
  • Subject is willing to maintain use or non-use of hormonal contraception
  • Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents

Exclusion Criteria:

  • Subserosal fibroids with bulk symptoms
  • Presence of type 0 intracavitary fibroids
  • Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
  • Any fibroid that obstructs access of the VizAblate probe
  • Postmenopausal by history
  • Desire for current or future fertility
  • Hemoglobin < 6 g/dl
  • Pregnancy
  • Evidence of disorders of hemostasis
  • Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM)
  • Short-term use of hormonal medication for management of bleeding
  • Evidence for current cervical dysplasia
  • Endometrial hyperplasia
  • Confirmed abdominal / pelvic malignancy within the previous five years
  • Active pelvic infection
  • Clinically significant adenomyosis
  • Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months
  • Current use of anticoagulant therapy
  • Need for emergency surgery to treat fibroid symptoms
  • Concomitant intrauterine polyps > 1.0 cm
  • Contraindication to MRI
  • Renal insufficiency
  • Uncontrolled hypertension lasting 2 years or more
  • One or more treatable fibroids that are calcified
  • Chronic pelvic pain
  • Presence of an extrauterine pelvic mass
  • Presence of a tubal implant for sterilization
  • Previous pelvic irradiation
  • Endometrial cavity length < 4.5 cm

Sites / Locations

  • Universidad Autonoma de Nuevo Leon (UANL)
  • Máxima Medisch Centrum
  • Vrije Universiteit Medisch Centrum
  • St. Antonius Ziekenhuis
  • Medisch Spectrum Twente
  • Royal London Hospital
  • Birmingham Women's NHS Foundation Trust
  • Princess Royal Hospital
  • Bradford Teaching Hospitals NHS Trust
  • University College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VizAblate treatment

Arm Description

VizAblate System: subject acts as her own control

Outcomes

Primary Outcome Measures

Mean percentage change in target fibroid perfused volume

Secondary Outcome Measures

Number of adverse events
Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
Percentage reduction in Menstrual Pictogram score
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire
Rate of surgical reintervention for menorrhagia
Return to normal daily activity

Full Information

First Posted
October 20, 2010
Last Updated
March 13, 2015
Sponsor
Gynesonics
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1. Study Identification

Unique Protocol Identification Number
NCT01226290
Brief Title
Fibroid Ablation Study
Acronym
FAST-EU
Official Title
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Investigational device changes; adequate enrollment achieved
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynesonics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine Fibroids, Menorrhagia
Keywords
uterine fibroid RF ablation, intrauterine ultrasound, VizAblate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VizAblate treatment
Arm Type
Experimental
Arm Description
VizAblate System: subject acts as her own control
Intervention Type
Device
Intervention Name(s)
VizAblate System
Intervention Description
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
Primary Outcome Measure Information:
Title
Mean percentage change in target fibroid perfused volume
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
Time Frame
procedure through 12 mo
Title
Percentage reduction in Menstrual Pictogram score
Time Frame
baseline through 12 months
Title
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire
Time Frame
baseline through 12 months
Title
Rate of surgical reintervention for menorrhagia
Time Frame
through 12 months
Title
Return to normal daily activity
Time Frame
2 weeks or until returned to normal activity
Other Pre-specified Outcome Measures:
Title
Subject satisfaction
Time Frame
3 month, 6 month, 12 months
Title
Anesthesia regimen
Time Frame
Day of procedure
Title
System ease of use
Time Frame
End of study
Title
Subject pain and tolerance of procedure
Time Frame
Day of procedure
Title
HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire
Time Frame
3 month, 6 month, 12 months
Title
EuroQOL EQ-5D
Time Frame
3 month, 6 month, 12 month
Title
Length of Stay
Time Frame
Day of procedure
Title
Nonsurgical reintervention for menorrhagia
Time Frame
30 day, 3 month, 6 month, 12 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 28 years of age or older Regular, consistent menstrual cycles History of excessive bleeding One Menstrual Pictogram score ≥ 120 during a one-month screening period Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20 Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc At least one fibroid must indent the endometrium Subject is not at material risk for pregnancy. Subject is willing to maintain use or non-use of hormonal contraception Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents Exclusion Criteria: Subserosal fibroids with bulk symptoms Presence of type 0 intracavitary fibroids Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc Any fibroid that obstructs access of the VizAblate probe Postmenopausal by history Desire for current or future fertility Hemoglobin < 6 g/dl Pregnancy Evidence of disorders of hemostasis Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM) Short-term use of hormonal medication for management of bleeding Evidence for current cervical dysplasia Endometrial hyperplasia Confirmed abdominal / pelvic malignancy within the previous five years Active pelvic infection Clinically significant adenomyosis Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months Current use of anticoagulant therapy Need for emergency surgery to treat fibroid symptoms Concomitant intrauterine polyps > 1.0 cm Contraindication to MRI Renal insufficiency Uncontrolled hypertension lasting 2 years or more One or more treatable fibroids that are calcified Chronic pelvic pain Presence of an extrauterine pelvic mass Presence of a tubal implant for sterilization Previous pelvic irradiation Endometrial cavity length < 4.5 cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Toub, MD
Organizational Affiliation
Gynesonics
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Autonoma de Nuevo Leon (UANL)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Máxima Medisch Centrum
City
Veldhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5500
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1007
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Royal London Hospital
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Birmingham Women's NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TG
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Haywards Health
State/Province
West Sussex
ZIP/Postal Code
RH16 3EJ
Country
United Kingdom
Facility Name
Bradford Teaching Hospitals NHS Trust
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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

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Fibroid Ablation Study

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