Back to resultsEvaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier (CLEAN)
Primary Purpose
Asherman Syndrome, Intrauterine Adhesion
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Womed Leaf
Sponsored by
About this trial
This is an interventional prevention trial for Asherman Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
- Women 30 years old or older;
- Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
- Subjects who can comply with the study follow-up and other study requirements.
Exclusion Criteria:
- Cavity length <4 or >8
- Perforation during ablation procedure
- Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
- History of cervical or endometrial cancer
- Active pelvic infection or history of pelvic peritonitis
- Known contraindication or hypersensitivity to Womed Leaf component
- Current participation in another clinical investigation that has not yet received the primary endpoint
- Any other condition that makes participation in the study contrary to the patient's best interests.
Sites / Locations
- Catharina Hospital
- St. Jans Gasthuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Womed Leaf group
No adhesion prevention group
Arm Description
Womed Leaf is inserted immediately after completion of the endometrial ablation.
Standard of care: no IUA prevention, no placebo after ablation
Outcomes
Primary Outcome Measures
Efficacy endpoint: AFS scale; a discrete number
Focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions) Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense. Sum: 1 = very light adhesions and 12 = extremely severe adhesions obstructing the whole cavity.
Safety endpoint 1.1: Assessment of cavity findings
Ability to perform a biopsy anywhere within the uterine cavity
Safety endpoint 1.2: Assessment of cavity findings
Ability to adequately visualise the endometrium to evaluate for pathologic change
Safety endpoint 1.3: Assessment of cavity findings
Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)
Serious adverse events
Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.
Secondary Outcome Measures
Each component of AFS score at second look hysteroscopy
Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense.
Binary rate of intrauterine adhesions on hysteroscopy
Yes/ No intrauterine adhesions are present
Change in menstrual bleeding
Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart
Level of dysmenorrhea
Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms
Level of patient satisfaction on ablation procedure
On a scale from 0 to 5 from the worst to the best health care possible; 0 = worst health care possible and 5 = best health care possible
Number of patients complaints
Number of patient complaints (i.e. complaints related to discharge or dyspareunia)
Number of subjects for whom a second ablation is possible
For each subject, the second look evaluator will assess whether it is possible to perform a second ablation if needed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05414760
Brief Title
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier
Acronym
CLEAN
Official Title
Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Remko P. Bosgraaf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Detailed Description
The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome, Intrauterine Adhesion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Womed Leaf group
Arm Type
Active Comparator
Arm Description
Womed Leaf is inserted immediately after completion of the endometrial ablation.
Arm Title
No adhesion prevention group
Arm Type
No Intervention
Arm Description
Standard of care: no IUA prevention, no placebo after ablation
Intervention Type
Device
Intervention Name(s)
Womed Leaf
Intervention Description
Womed Leaf™ is a sterile, degradable film of poly(D,L-lactide) (PLA) and poly(ethylene oxide) (PEO). PEO is a biocompatible polymer with anti-adhesion and swelling properties. It is polymerized with hydrophobic PLA to form a degradable film. Womed Leaf™ is inserted in the uterine cavity by a gynaecologist surgeon with a 5 mm diameter flexible inserter. Once released, the film unfolds and grows into the uterine cavity to create a mechanical barrier and keep the uterine walls separated for approximately one week. It is then degraded and discharged naturally through the cervix.
Primary Outcome Measure Information:
Title
Efficacy endpoint: AFS scale; a discrete number
Description
Focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions) Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense. Sum: 1 = very light adhesions and 12 = extremely severe adhesions obstructing the whole cavity.
Time Frame
4-8 weeks after surgery
Title
Safety endpoint 1.1: Assessment of cavity findings
Description
Ability to perform a biopsy anywhere within the uterine cavity
Time Frame
4-8 weeks after surgery
Title
Safety endpoint 1.2: Assessment of cavity findings
Description
Ability to adequately visualise the endometrium to evaluate for pathologic change
Time Frame
4-8 weeks after surgery
Title
Safety endpoint 1.3: Assessment of cavity findings
Description
Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)
Time Frame
4-8 weeks after surgery
Title
Serious adverse events
Description
Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Each component of AFS score at second look hysteroscopy
Description
Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense.
Time Frame
4-8 weeks after surgery
Title
Binary rate of intrauterine adhesions on hysteroscopy
Description
Yes/ No intrauterine adhesions are present
Time Frame
4-8 weeks after surgery
Title
Change in menstrual bleeding
Description
Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart
Time Frame
3 months after surgery
Title
Level of dysmenorrhea
Description
Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms
Time Frame
Before surgery and after 3 months
Title
Level of patient satisfaction on ablation procedure
Description
On a scale from 0 to 5 from the worst to the best health care possible; 0 = worst health care possible and 5 = best health care possible
Time Frame
Immediately after the surgery
Title
Number of patients complaints
Description
Number of patient complaints (i.e. complaints related to discharge or dyspareunia)
Time Frame
3 months after surgery
Title
Number of subjects for whom a second ablation is possible
Description
For each subject, the second look evaluator will assess whether it is possible to perform a second ablation if needed.
Time Frame
4-8 weeks after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
Women 30 years old or older;
Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
Subjects who can comply with the study follow-up and other study requirements.
Exclusion Criteria:
Cavity length <4 or >8
Perforation during ablation procedure
Previous adhesiolysis procedure or diagnosis of Asherman's disease.
Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
History of cervical or endometrial cancer
Active pelvic infection or history of pelvic peritonitis
Known contraindication or hypersensitivity to Womed Leaf component
Current participation in another clinical investigation that has not yet received the primary endpoint
Any other condition that makes participation in the study contrary to the patient's best interests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remko Bosgraaf
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
St. Jans Gasthuis
City
Weert
ZIP/Postal Code
6001BE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The anonymized data will become available and reusable for other researchers upon reasonable request according to GCP and FAIR principles. All research data will be handled confidentially in accordance with legislation and conditions imposed by Autoriteit Persoonsgegevens.
Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years
IPD Sharing Time Frame
Immediately after article publication and during 5 years
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal
Learn more about this trial
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier
We'll reach out to this number within 24 hrs