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

NCT ID: NCT05414760

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2024-02-05

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.

Conditions

Asherman Syndrome; Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Womed Leaf group

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

Group Type: ACTIVE_COMPARATOR

Womed Leaf

Intervention Type: 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.

No adhesion prevention group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Remko P. Bosgraaf

OTHER

Sponsor Role: lead

Responsible Party

Remko P. Bosgraaf

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Remko Bosgraaf

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Hospital

Eindhoven, , Netherlands

St. Jans Gasthuis

Weert, , Netherlands

Countries

Netherlands

Other Identifiers

CLEAN

Identifier Type: -

Identifier Source: org_study_id