PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

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.

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.

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:

Pre-operative 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

Per-operative exclusion criteria:

• 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