PREvention of intrauterine adhesion after hysteroscopic surgery with novel deGradable film
- Conditions
- Adhesions after hysteroscopy100385951004682810029903
- Registration Number
- NL-OMON49341
- Lead Sponsor
- WOMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* 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
* Current pregnancy
* Abnormal uterine cavity
* Known or suspected endometrial hyperplasia
* Medical history of cervical or endometrial cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints for safety and efficacy:<br /><br><br /><br>Safety endpoint: number and type of device-related adverse events (AE) up to 30<br /><br>days:<br /><br>* Per-operative AEs during device use (cervical trauma, uterine perforation*)<br /><br>* Polymer film tolerance defined as fever, pain or bleeding between 48 hours<br /><br>post procedure and 30 days<br /><br><br /><br>An Interim Analysis of the safety endpoint will be conducted on the first 10<br /><br>subjects at 30 day follow-up.<br /><br><br /><br>Efficacy endpoint: freedom from intrauterine adhesion at second look<br /><br>hysteroscopy between 4 and 8 weeks, and evaluation of severity according to<br /><br>American Fertility Society (AFS) and European Society of Gynecological<br /><br>Endoscopy classifications systems of adhesions. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoints:<br /><br><br /><br>1. Number, type and severity of adverse events (AE) at 30 days<br /><br>2. Performance: device technical success, defined as success of the following 2<br /><br>steps :<br /><br>a. Menstrual bleeding according to Higham score<br /><br>4. Presence of Womed Leaf residuals in the uterus at hysteroscopic control<br /><br>after 4-8 weeks</p><br>