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CollaGUARD Adhesion Barrier

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ClinicalTrials.gov Identifier: NCT02348541
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Innocoll

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

Condition or disease Intervention/treatment Phase
Hysteroscopic Adhesiolysis Device: CollaGUARD Early Phase 1

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 Design
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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: Prevention
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

Arms and Interventions
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Arm Intervention/treatment
CollaGUARD Device: CollaGUARD


Outcome Measures
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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


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

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)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02348541


Locations
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Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Sponsors and Collaborators
Innocoll
Investigators
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Study Director: David Prior, PhD Sponsor GmbH
More Information
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Responsible Party: Innocoll
ClinicalTrials.gov Identifier: NCT02348541    
Other Study ID Numbers: INN-CG-001
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes