Usability of the CollaGUARD Adhesion Barrier Following Hy... | NCT02348541

Studies
Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

NCT02348541

Sponsor

Innocoll

Status

Completed

Last Update Posted

Sep 10, 2021Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Hysteroscopic Adhesiolysis

Interventions

CollaGUARD

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 19, 2015

First Submission Date that Met QC Criteria

Jan 27, 2015

First Posted Date

Jan 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2021

Last Update Posted Date

Sep 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
CollaGUARD	Other		Device: CollaGUARD

Name	Type	Description	Arm Group Labels	Other Names
CollaGUARD	Device		CollaGUARD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire	surgeon completed questionnaire	following initial hysteroscopy

Secondary Outcomes

Measure	Description	Time Frame
Number of de novo adhesion and adhesion reformation	assessed during follow-up hysteroscopy	9 weeks post initial hysteroscopy
Change in severity of adhesions	European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Prior, PhD	Sponsor GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sint Lucas Andreas Ziekenhuis		Amsterdam			Netherlands
Spaarne Ziekenhuis