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
|Condition or disease||Intervention/treatment||Phase|
|Hysteroscopic Adhesiolysis||Device: CollaGUARD||Early Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire [ Time Frame: following initial hysteroscopy ]surgeon completed questionnaire
- 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
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
|Sint Lucas Andreas Ziekenhuis|
|Study Director:||David Prior, PhD||Sponsor GmbH|