Status:
COMPLETED
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Lead Sponsor:
Womed
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
40-70 years
Phase:
NA
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 ...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04381728
Start Date
November 18 2019
End Date
March 15 2021
Last Update
November 9 2021
Active Locations (6)
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1
UZ Gent
Ghent, Belgium
2
CHU Nîmes
Nîmes, France
3
CHU Bicêtre (APHP)
Paris, France
4
Bergman Clinics
Amsterdam, Netherlands