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Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Primary Purpose

Hysteroscopic Adhesiolysis

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

CollaGUARD

About this trial

This is an interventional treatment trial for Hysteroscopic Adhesiolysis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Sint Lucas Andreas Ziekenhuis
Spaarne Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CollaGUARD

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire

surgeon completed questionnaire

Secondary Outcome Measures

Number of de novo adhesion and adhesion reformation

assessed during follow-up hysteroscopy

Change in severity of adhesions

European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)

Degradation of CollaGUARD

assessed via ultrasound

Full Information

NCT ID

NCT02348541

First Posted

January 19, 2015

Last Updated

September 2, 2021

Sponsor

Innocoll

1. Study Identification

Unique Protocol Identification Number

NCT02348541

Brief Title

Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Official Title

A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innocoll

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hysteroscopic Adhesiolysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CollaGUARD

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

CollaGUARD

Primary Outcome Measure Information:

Title

Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire

Description

surgeon completed questionnaire

Time Frame

following initial hysteroscopy

Secondary Outcome Measure Information:

Title

Number of de novo adhesion and adhesion reformation

Description

assessed during follow-up hysteroscopy

Time Frame

9 weeks post initial hysteroscopy

Title

Change in severity of adhesions

Description

European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)

Time Frame

9 weeks post initial hysteroscopy

Title

Degradation of CollaGUARD

Description

assessed via ultrasound

Time Frame

2 weeks post initial hysteroscopy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Prior, PhD

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Sint Lucas Andreas Ziekenhuis

City

Amsterdam

Country

Netherlands

Facility Name

Spaarne Ziekenhuis

City

Hoofddorp

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

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