Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

September 2, 2021 updated by: Innocoll

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Sint Lucas Andreas Ziekenhuis
      • Hoofddorp, Netherlands
        • Spaarne Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CollaGUARD
Device: CollaGUARD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
Time Frame: following initial hysteroscopy
surgeon completed questionnaire
following initial hysteroscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of de novo adhesion and adhesion reformation
Time Frame: 9 weeks post initial hysteroscopy
assessed during follow-up hysteroscopy
9 weeks post initial hysteroscopy
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)
9 weeks post initial hysteroscopy
Degradation of CollaGUARD
Time Frame: 2 weeks post initial hysteroscopy
assessed via ultrasound
2 weeks post initial hysteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innocoll

Investigators

  • Study Director: David Prior, PhD, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (ESTIMATE)

January 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INN-CG-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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