Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Innocoll

Status

Completed

Conditions

Hysteroscopic Adhesiolysis

Treatments

Device: CollaGUARD

Study type

Interventional

Funder types

Industry

Identifiers

NCT02348541

INN-CG-001

Details and patient eligibility

About

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Full 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.

Enrollment

9 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)