PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film (NCT04381728) | Clinical Trial Compass
CompletedNot Applicable
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Belgium, France, Netherlands23 participantsStarted 2019-11-18
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety (Adverse Events)
Timeframe: 30 days
2
Efficacy (Rate of Patient With no IUA)
Timeframe: At second look hysteroscopy between 4 and 8 weeks
3
Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
Timeframe: At second look hysteroscopy between 4 and 8 weeks
4
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
Timeframe: At second look hysteroscopy between 4 and 8 weeks