Skip to main content
OpenTrials
Completed

NCT Number: NCT02348541

Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hysteroscopic Adhesiolysis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CollaGUARD

Device

Primary outcomes

  1. Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire

    Time frame: following initial hysteroscopy

    surgeon completed questionnaire

Secondary outcomes

  1. Number of de novo adhesion and adhesion reformation

    Time frame: 9 weeks post initial hysteroscopy

    assessed during follow-up hysteroscopy

  2. Change in severity of adhesions

    Time frame: 9 weeks post initial hysteroscopy

    European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)

  3. Degradation of CollaGUARD

    Time frame: 2 weeks post initial hysteroscopy

    assessed via ultrasound

Sponsors and collaborators

Lead sponsor

Innocoll

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2015
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.