Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Not Applicable

Completed

• Conditions: Hysteroscopic Adhesiolysis
• Interventions: Device: CollaGUARD

• Registration Number: NCT02348541
• Lead Sponsor: Innocoll

Brief Summary

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Detailed Description

Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.

CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.

This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
• Willing to use additional contraception throughout study

Exclusion Criteria

• Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
• Has suffered or currently suffers from a gynaecological malignancy
• Has undergone a previous hysteroscopic surgery (such as removal of fibroids)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CollaGUARD	CollaGUARD	-

Primary Outcome Measures

Name	Time	Method
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire	following initial hysteroscopy	surgeon completed questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in severity of adhesions	9 weeks post initial hysteroscopy	European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)
Number of de novo adhesion and adhesion reformation	9 weeks post initial hysteroscopy	assessed during follow-up hysteroscopy
Degradation of CollaGUARD	2 weeks post initial hysteroscopy	assessed via ultrasound

Trial Locations

Locations (2)

Sint Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands