Clinical trial NCT04381728: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Official title: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: myomectomy
Intrauterine adhesion
hysteroscopy
Lead sponsor: Womed
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 \< 6cm or \>9cm
* Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator

Primary outcomes:
measure: Safety (Adverse Events)
timeFrame: 30 days
measure: Efficacy (Rate of Patient With no IUA)
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
timeFrame: At second look hysteroscopy between 4 and 8 weeks
measure: Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
timeFrame: At second look hysteroscopy between 4 and 8 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 30 days
measure: Device Technical Success
timeFrame: During operation: T=0
measure: Womed Leaf Residuals
timeFrame: At second look hysteroscopy: 4-8 weeks
measure: Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge
timeFrame: At second look hysteroscopy: 4-8 weeks
measure: Device Manipulation
timeFrame: During intervention: T=0
measure: Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))
timeFrame: At second look hysteroscopy: 4-8 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: CHU Bicêtre (APHP)
city: Amsterdam
country: Netherlands
facility: Bergman Clinics
city: Amsterdam
country: Netherlands
facility: Zaans Medical Center
city: Zwolle
country: Netherlands
facility: Isala Zwolle
Study officials:
References:
citation: 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.