Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02348541

Enrollment

Registered

2015-01-28

Start date

2014-12-31

Completion date

2015-09-30

Last updated

2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DEVICECollaGUARD

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of de novo adhesion and adhesion reformation	9 weeks post initial hysteroscopy	assessed during follow-up hysteroscopy
Change in severity of adhesions	9 weeks post initial hysteroscopy	European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)
Degradation of CollaGUARD	2 weeks post initial hysteroscopy	assessed via ultrasound

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026