Adhesions after hysteroscopy
Conditions
Interventions
Womed Leaf* is inserted in the uterine cavity by a gynecologist surgeon as a
film folded into a 5 mm diameter flexible inserter. Once released, the film
will unfold and swell into the uterine cavity
Sponsors
WOMED
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Women * 40 years AND no childbearing wish until the second look hysteroscopy, OR history of permanent sterilization; * Subject scheduled for myomectomy for one or more myoma(s) where one myoma is at least 10mm 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
Exclusion criteria: * Current pregnancy * Abnormal uterine cavity * Known or suspected endometrial hyperplasia * Medical history of cervical or endometrial cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for safety and efficacy: Safety endpoint: number and type of device-related adverse events (AE) up to 30 days: * Per-operative AEs during device use (cervical trauma, uterine perforation*) * Polymer film tolerance defined as fever, pain or bleeding between 48 hours post procedure and 30 days An Interim Analysis of the safety endpoint will be conducted on the first 10 subjects at 30 day follow-up. Efficacy endpoint: freedom from intrauterine adhesion at second look hysteroscopy between 4 and 8 weeks, and evaluation of severity according to American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: 1. Number, type and severity of adverse events (AE) at 30 days 2. Performance: device technical success, defined as success of the following 2 steps : a. Menstrual bleeding according to Higham score 4. Presence of Womed Leaf residuals in the uterus at hysteroscopic control after 4-8 weeks | — |
Countries
Netherlands
Outcome results
None listed