PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

NCT ID: NCT04381728

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-03-15

Brief Summary

Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

Detailed Description

Intrauterine adhesions (IUA) are defined as "fibrous strings at opposing walls of the uterus and/or cervix leading to partial or complete obliteration of the cavity". IUAs are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complications and infertility.

Womed Leaf™ is a sterile, degradable polymer film specifically design for intrauterine use. It is inserter in the uterus like an intrauterine device. Once released it will self-deploy into the uterine cavity to form a mechanical barrier keeping uterus walls separated during healing, for several days, thus preventing the formation or recurrence of intrauterine adhesions. It is degraded and discharged naturally through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is a prospective multicenter, single arm study, designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy in preventing IUA at second look hysteroscopy.

Conditions

Intrauterine Adhesion

Keywords

myomectomy; Intrauterine adhesion; hysteroscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Womed Leaf

At the end of the hysteroscopic myomectomy, Womed Leaf is delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound will be performed to assess the positioning of the uterine film.

Another ultrasound will be performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.

A second look hysteroscopy will performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Group Type: EXPERIMENTAL

Womed Leaf

Intervention Type: DEVICE

Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.

Interventions

Womed Leaf

Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women ≥ 40 years AND no childbearing wish, OR history of permanent sterilization;
• Subject scheduled for hysteroscopic myomectomy for one or more myoma(s) where one myoma is at least 10 mm in size (≥10mm) as estimated by pre-operative ultrasound measurement of the largest diameter,
• Hysterometry prior to device insertion ≥ 6cm and ≤ 9cm.
• Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee prior to participating in this clinical investigation.
• Subjects who can comply with the study follow-up or other study requirements

Exclusion Criteria

• Current pregnancy
• Abnormal uterine cavity according to ESHRE classification I to VI, such as unicornis, bicornis, septate, duplex
• Known or suspected endometrial hyperplasia
• Medical history of cervical or endometrial cancer
• Active pelvic infection or medical history of pelvic peritonitis
• Intrauterine device in situ
• Known contraindication or hypersensitivity to PEO or PLA, and to medications such as aspirin….
• Concurrent medical condition with a life expectancy of less than 12 months
• Full endometrial ablation

• Adenomyosis
• Inflammation (endometritis)
• Abnormal uterine cavity
• Hysterometry < 6cm or >9cm
• Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Womed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Gent

Ghent, , Belgium

CHU Nîmes

Nîmes, , France

CHU Bicêtre (APHP)

Paris, , France

Bergman Clinics

Amsterdam, , Netherlands

Zaans Medical Center

Amsterdam, , Netherlands

Isala Zwolle

Zwolle, , Netherlands

Countries

Belgium; France; Netherlands

References

Weyers S, Capmas P, Huberlant S, Dijkstra JR, Hooker AB, Hamerlynck T, Debras E, De Tayrac R, Thurkow AL, Fernandez H. Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):151-157. doi: 10.1016/j.jmig.2021.07.017. Epub 2021 Jul 31.

Reference Type: DERIVED

PMID: 34343712 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PREG1

Identifier Type: -

Identifier Source: org_study_id