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Completed

NCT Number: NCT05414760

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

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

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Key information

Conditions

Asherman Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Intrauterine Adhesion Urogenital Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital, Eindhoven, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Womed Leaf

Device

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 outcomes

  1. Efficacy endpoint: AFS scale; a discrete number

    Time frame: 4-8 weeks after surgery

    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.

  2. Safety endpoint 1.1: Assessment of cavity findings

    Time frame: 4-8 weeks after surgery

    Ability to perform a biopsy anywhere within the uterine cavity

  3. Safety endpoint 1.2: Assessment of cavity findings

    Time frame: 4-8 weeks after surgery

    Ability to adequately visualise the endometrium to evaluate for pathologic change

  4. Safety endpoint 1.3: Assessment of cavity findings

    Time frame: 4-8 weeks after surgery

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

  5. Serious adverse events

    Time frame: 3 months after surgery

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

Secondary outcomes

  1. Each component of AFS score at second look hysteroscopy

    Time frame: 4-8 weeks after surgery

    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.

  2. Binary rate of intrauterine adhesions on hysteroscopy

    Time frame: 4-8 weeks after surgery

    Yes/ No intrauterine adhesions are present

  3. Change in menstrual bleeding

    Time frame: 3 months after surgery

    Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart

  4. Level of dysmenorrhea

    Time frame: Before surgery and after 3 months

    Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms

  5. Level of patient satisfaction on ablation procedure

    Time frame: Immediately after the surgery

    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

  6. Number of patients complaints

    Time frame: 3 months after surgery

    Number of patient complaints (i.e. complaints related to discharge or dyspareunia)

  7. Number of subjects for whom a second ablation is possible

    Time frame: 4-8 weeks after surgery

    For each subject, the second look evaluator will assess whether it is possible to perform a second ablation if needed.

Sponsors and collaborators

Lead sponsor

Remko P. Bosgraaf

Other

Registry information

Official study title

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

Acronym: CLEAN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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