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

NCT05414760 | Completed DMC

• 1 other identifier: CLEAN
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asherman Syndrome; Intrauterine Adhesion

Outcome Measures

Primary Outcomes (5)

• 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

• Safety endpoint 1.1: Assessment of cavity findings

  Ability to perform a biopsy anywhere within the uterine cavity

  4-8 weeks after surgery

• Safety endpoint 1.2: Assessment of cavity findings

  Ability to adequately visualise the endometrium to evaluate for pathologic change

  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…)

  4-8 weeks after surgery

• Serious adverse events

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

  3 months after surgery

Secondary Outcomes (7)

• Each component of AFS score at second look hysteroscopy

  4-8 weeks after surgery

• Binary rate of intrauterine adhesions on hysteroscopy

  4-8 weeks after surgery

• Change in menstrual bleeding

  3 months after surgery

• Level of dysmenorrhea

  Before surgery and after 3 months

• Level of patient satisfaction on ablation procedure

  Immediately after the surgery

Study Arms (2)

Womed Leaf group

ACTIVE COMPARATOR

Womed Leaf is inserted immediately after completion of the endometrial ablation.

Device: Womed Leaf

No adhesion prevention group

NO INTERVENTION

Standard of care: no IUA prevention, no placebo after ablation

Interventions

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.

Womed Leaf group

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Remko P. Bosgraaf: lead

Study Sites (2)

Catharina Hospital

Eindhoven, 5623EJ, Netherlands

Location

St. Jans Gasthuis

Weert, 6001BE, Netherlands

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Remko Bosgraaf

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 10, 2022
• Study Start: November 11, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after article publication and during 5 years
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

NL (2)