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

Remko P. Bosgraaf1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Asherman Syndrome Intrauterine Adhesion

Interventions

Womed LeafDEVICE

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.

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (2)

Catharina Hospital

Eindhoven, Netherlands

St. Jans Gasthuis

Weert, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 4-8 weeks after surgery

Safety endpoint 1.1: Assessment of cavity findings

Ability to perform a biopsy anywhere within the uterine cavity

Time frame: 4-8 weeks after surgery

Safety endpoint 1.2: Assessment of cavity findings

Ability to adequately visualise the endometrium to evaluate for pathologic change

Time frame: 4-8 weeks after surgery

Safety endpoint 1.3: Assessment of cavity findings

Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)

Time frame: 4-8 weeks after surgery

Serious adverse events

Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.

Time frame: 3 months after surgery

Secondary Outcomes

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.

Time frame: 4-8 weeks after surgery

Binary rate of intrauterine adhesions on hysteroscopy

Data from ClinicalTrials.gov

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