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A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding (CLARITY)

Primary Purpose

Menorrhagia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cerene(R) Cryotherapy Device
Sponsored by
Channel Medsystems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring heavy menstrual bleeding, endometrial ablation

Eligibility Criteria

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

Inclusion Criteria:

  • Refractory heavy menstrual bleeding with no definable organic cause
  • Female subject age 25 to 50 years, inclusive
  • Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm
  • Sufficient myometrial thickness
  • Documented excessive menstrual blood loss within 3 months of informed consent
  • Premenopausal confirmed by follicle stimulating hormone (FSH) measurement
  • Agrees to use a reliable form of contraception following ablation treatment
  • Provides written informed consent using a form that has been approved by the reviewing ethics committee
  • Agrees to follow-up exams and data collection requirements
  • Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram
  • Has predictable, cyclic menstrual cycles

Exclusion Criteria:

  • Pregnant or has a desire to conceive
  • Endometrial hyperplasia as confirmed by histology
  • Active endometritis
  • Active pelvic inflammatory disease
  • Active sexually transmitted disease (STD)
  • Presence of bacteremia, sepsis, or other active systemic infection
  • Active infection of the genitals, vagina, cervix, or uterus
  • Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
  • Known clotting defects or bleeding disorders
  • Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards.
  • Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section).
  • Previous low transverse cesarean section where the myometrial wall thickness is insufficient
  • Previous endometrial ablation procedure
  • Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment
  • Presence of an implantable contraceptive device
  • Currently on medications that could thin the myometrial muscle
  • Currently on anticoagulants
  • Abnormal or obstructed cavity
  • Currently using an intrauterine device (IUD) and unwilling to remove the IUD
  • Post-partum ≤ 6-months
  • Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
  • Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements

Sites / Locations

  • WomanCare PC
  • The Advance Gynecologic Surgery Institute
  • Women's Health Advantage
  • Basinski LLC
  • Asheville Women's Medical Center
  • Seven Hills Women's Health
  • Amy Brenner MD and Associates, LLC
  • Vanderbilt University Medical Center
  • Premier Clinical Research
  • Allan Centre
  • LaSalle Hospital
  • Hospital Universitario de la Universidad Autónoma de Nuevo Leon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endometrial Cryoablation

Arm Description

Outcomes

Primary Outcome Measures

Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.

Secondary Outcome Measures

Dysmennorhea
Subjects were queried regarding if they suffer from dysmenorrhea (painful cramping associated with menstruation). The subject was asked to rate their level of dysmenorrhea on a scale from 0 to 5, with 0 indicating no symptoms and 5 indicating very severe symptoms. A score of 0 was considered better than a score of 5.
Amenorrhea
Pictorial blood loss assessment (PBLAC) score = 0 Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.
Investigator Evaluation of the Uterine Cavity
Investigator Assessment of Cavity Findings
Questions to the investigator
Anesthesia and Pain Medications at Treatment
Subject Rating of Pain During Treatment and Day One Post-Treatment
Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.

Full Information

First Posted
July 21, 2016
Last Updated
December 9, 2020
Sponsor
Channel Medsystems
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1. Study Identification

Unique Protocol Identification Number
NCT02842736
Brief Title
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
Acronym
CLARITY
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Channel Medsystems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
heavy menstrual bleeding, endometrial ablation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endometrial Cryoablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cerene(R) Cryotherapy Device
Primary Outcome Measure Information:
Title
Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Time Frame
12 months
Title
Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
Description
Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Dysmennorhea
Description
Subjects were queried regarding if they suffer from dysmenorrhea (painful cramping associated with menstruation). The subject was asked to rate their level of dysmenorrhea on a scale from 0 to 5, with 0 indicating no symptoms and 5 indicating very severe symptoms. A score of 0 was considered better than a score of 5.
Time Frame
12 Months
Title
Amenorrhea
Description
Pictorial blood loss assessment (PBLAC) score = 0 Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding.
Time Frame
12 Months
Title
Investigator Evaluation of the Uterine Cavity
Time Frame
12 Months
Title
Investigator Assessment of Cavity Findings
Description
Questions to the investigator
Time Frame
12 Months
Title
Anesthesia and Pain Medications at Treatment
Time Frame
Day of Treatment
Title
Subject Rating of Pain During Treatment and Day One Post-Treatment
Description
Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.
Time Frame
Day of Treatment and Day One Post-Treatment
Other Pre-specified Outcome Measures:
Title
Subjects' Report of Their Last Menstrual Period
Description
Subjects were asked to describe their last menstrual period
Time Frame
36 months
Title
Menstrual Impact Questionnaire
Description
Subjects' Report of Activity Limitations
Time Frame
36 months
Title
Premenstrual Symptoms Impact Survey
Description
Subjects' Report of Pre-Menstrual Symptoms (PMS)
Time Frame
36 months
Title
Subject Satisfaction
Description
Subject's level of satisfaction with the results of her Cerene treatment
Time Frame
36 Months
Title
Subject Recommendation
Description
Subjects' reported level of recommendation to a friend/family
Time Frame
36 months
Title
Procedure Time
Description
Device insertion to device removal
Time Frame
Day of Treatment
Title
Return to Normal Daily Activities
Time Frame
Two-Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Refractory heavy menstrual bleeding with no definable organic cause Female subject age 25 to 50 years, inclusive Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm Sufficient myometrial thickness Documented excessive menstrual blood loss within 3 months of informed consent Premenopausal confirmed by follicle stimulating hormone (FSH) measurement Agrees to use a reliable form of contraception following ablation treatment Provides written informed consent using a form that has been approved by the reviewing ethics committee Agrees to follow-up exams and data collection requirements Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram Has predictable, cyclic menstrual cycles Exclusion Criteria: Pregnant or has a desire to conceive Endometrial hyperplasia as confirmed by histology Active endometritis Active pelvic inflammatory disease Active sexually transmitted disease (STD) Presence of bacteremia, sepsis, or other active systemic infection Active infection of the genitals, vagina, cervix, or uterus Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years Known clotting defects or bleeding disorders Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards. Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section). Previous low transverse cesarean section where the myometrial wall thickness is insufficient Previous endometrial ablation procedure Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment Presence of an implantable contraceptive device Currently on medications that could thin the myometrial muscle Currently on anticoagulants Abnormal or obstructed cavity Currently using an intrauterine device (IUD) and unwilling to remove the IUD Post-partum ≤ 6-months Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements
Facility Information:
Facility Name
WomanCare PC
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
The Advance Gynecologic Surgery Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Basinski LLC
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Asheville Women's Medical Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Seven Hills Women's Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Amy Brenner MD and Associates, LLC
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Allan Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7G9
Country
Canada
Facility Name
LaSalle Hospital
City
Lasalle
State/Province
Quebec
ZIP/Postal Code
H8P 1C1
Country
Canada
Facility Name
Hospital Universitario de la Universidad Autónoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
66460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
35983177
Citation
Curlin HL, Anderson TL. Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study. Int J Womens Health. 2022 Aug 10;14:1083-1092. doi: 10.2147/IJWH.S371044. eCollection 2022.
Results Reference
derived
PubMed Identifier
34839060
Citation
Curlin H, Cholkeri-Singh A, Leal JGG, Anderson T. Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device. J Minim Invasive Gynecol. 2022 Mar;29(3):440-447. doi: 10.1016/j.jmig.2021.11.016. Epub 2021 Nov 25.
Results Reference
derived
PubMed Identifier
32835865
Citation
Curlin HL, Cintron LC, Anderson TL. A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. J Minim Invasive Gynecol. 2021 Apr;28(4):899-908. doi: 10.1016/j.jmig.2020.08.013. Epub 2020 Aug 22.
Results Reference
derived

Learn more about this trial

A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

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