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Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348541
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : September 10, 2021
Information provided by (Responsible Party):

Brief Summary:
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Condition or disease Intervention/treatment Phase
Hysteroscopic Adhesiolysis Device: CollaGUARD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
CollaGUARD Device: CollaGUARD

Primary Outcome Measures :
  1. Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire [ Time Frame: following initial hysteroscopy ]
    surgeon completed questionnaire

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02348541

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Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Sponsors and Collaborators
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Study Director: David Prior, PhD Sponsor GmbH
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Responsible Party: Innocoll Identifier: NCT02348541    
Other Study ID Numbers: INN-CG-001
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Adhesions
Pathologic Processes