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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

Tracking Information
First Submitted Date  ICMJE January 19, 2015
First Posted Date  ICMJE January 28, 2015
Last Update Posted Date June 13, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire [ Time Frame: following initial hysteroscopy ]
surgeon completed questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
  • Number of de novo adhesion and adhesion reformation [ Time Frame: 9 weeks post initial hysteroscopy ]
    assessed during follow-up 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)
  • Degradation of CollaGUARD [ Time Frame: 2 weeks post initial hysteroscopy ]
    assessed via ultrasound
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CollaGUARD Adhesion Barrier
Official Title  ICMJE A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Brief Summary Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hysteroscopic Adhesiolysis
Intervention  ICMJE Device: CollaGUARD
Study Arms  ICMJE CollaGUARD
Intervention: Device: CollaGUARD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2015)
10
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02348541
Other Study ID Numbers  ICMJE INN-CG-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innocoll
Study Sponsor  ICMJE Innocoll
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Prior, PhD Sponsor GmbH
PRS Account Innocoll
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP