Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Hysteroscopic Adhesiolysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348541
• Other study ID #: INN-CG-001
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2021
• Source: Innocoll
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hysteroscopic Adhesiolysis
• Tissue Adhesions

Intervention

Device:
• CollaGUARD

Locations

Country	Name	City	State
Netherlands	Sint Lucas Andreas Ziekenhuis	Amsterdam
Netherlands	Spaarne Ziekenhuis	Hoofddorp

Sponsors (1)

Lead Sponsor	Collaborator
Innocoll

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire	surgeon completed questionnaire	following initial hysteroscopy
Secondary	Number of de novo adhesion and adhesion reformation	assessed during follow-up hysteroscopy	9 weeks post initial hysteroscopy
Secondary	Change in severity of adhesions	European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)	9 weeks post initial hysteroscopy
Secondary	Degradation of CollaGUARD	assessed via ultrasound	2 weeks post initial hysteroscopy