NCT02348541

Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Innocoll · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hysteroscopic Adhesiolysis

Interventions

Type	Name	Description
DEVICE	CollaGUARD

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-01-28
• Last updated: 2021-09-10

Locations

2 sites across 1 country: Netherlands