Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-09-30

Brief Summary

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Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

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Detailed Description

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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

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Hysteroscopic Adhesiolysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CollaGUARD

Group Type OTHER

CollaGUARD

Intervention Type DEVICE

Interventions

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CollaGUARD

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No