Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier

Intrauterine Adhesion Clinical Trial

— CLEAN  

Official title:

Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414760
• Other study ID #: CLEAN
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: February 5, 2024

Study information

• Verified date: February 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asherman Syndrome
• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• Womed Leaf
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.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven
Netherlands	St. Jans Gasthuis	Weert

Sponsors (1)

Lead Sponsor	Collaborator
Remko P. Bosgraaf

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-8 weeks after surgery
Primary	Safety endpoint 1.1: Assessment of cavity findings	Ability to perform a biopsy anywhere within the uterine cavity	4-8 weeks after surgery
Primary	Safety endpoint 1.2: Assessment of cavity findings	Ability to adequately visualise the endometrium to evaluate for pathologic change	4-8 weeks after surgery
Primary	Safety endpoint 1.3: Assessment of cavity findings	Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)	4-8 weeks after surgery
Primary	Serious adverse events	Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.	3 months after surgery
Secondary	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.	4-8 weeks after surgery
Secondary	Binary rate of intrauterine adhesions on hysteroscopy	Yes/ No intrauterine adhesions are present	4-8 weeks after surgery
Secondary	Change in menstrual bleeding	Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart	3 months after surgery
Secondary	Level of dysmenorrhea	Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms	Before surgery and after 3 months
Secondary	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	Immediately after the surgery
Secondary	Number of patients complaints	Number of patient complaints (i.e. complaints related to discharge or dyspareunia)	3 months after surgery
Secondary	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.	4-8 weeks after surgery