N/A
N=23
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Intrauterine Adhesion
Bottom Line
View on ClinicalTrials.gov: NCT04381728 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Safety (Adverse Events) — 0 device related adverse event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Womed Leaf (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Womed
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Adverse Events) |
— | — |
| PRIMARY Efficacy (Rate of Patient With no IUA) |
20 | — |
| PRIMARY Efficacy (Intrauterine Adhesion Severity According to AFS Classification) |
2; 1 | — |
| PRIMARY Efficacy (Intrauterine Adhesion Severity According to ESGE Classification) |
1; 2 | — |
| SECONDARY Adverse Events |
3 | — |
| SECONDARY Device Technical Success |
23 | — |
| SECONDARY Womed Leaf Residuals |
— | — |
| SECONDARY Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge |
6 | — |
| SECONDARY Device Manipulation |
2 | — |
| SECONDARY Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing)) |
1.9 | — |
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.
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
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 9cm
- Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator
Data sourced from ClinicalTrials.gov (NCT04381728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.