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

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

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.

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)