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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Be a female >=18 and <= 45 years of age
- Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
- Willing to use additional contraception until the study is completed
- Understand and be willing to follow all aspects of the study protocol and is able to provide written Informed Consent prior to any study-related procedures being performed

Exclusion Criteria

- Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
- Be a female of childbearing potential not using a reliable means of contraception
- Has suffered or currently suffers from a gynaecological malignancy
- Has a current genital infection
- Has a known or suspected hypersensitivity to collagen
- Has a known or suspected increased risk of infections (due to e.g. (auto)immune diseases or taking medications influencing infection risk)
- Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
- Has a condition or be in a situation that, in the Investigator*s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject*s participation in the study
- No adhesion formation present in the uterus
- Severe adhesion formation which cannot be removed in one procedure
- Has a condition or be in a situation which could only be determined during the hysteroscopic procedure that, in the Investigator*s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject*s participation in the study

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this clinical investigation is to determine the<br /><br>usability of the use of CollaGUARD in hysteroscopic adhesiolysis.<br /><br><br /><br>Safety shall be assessed by means of recording serious adverse events. The<br /><br>safety endpoint of this trial is freedom from unexpected serious device related<br /><br>adverse events during the complete study period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of this clinical investigation are:<br /><br>- The number of de novo adhesions and adhesion reformations<br /><br>- Change in severity of the adhesions based on the ESGE and mAFS IUA<br /><br>classification scale at all follow-up visits<br /><br>- Product positioning and degradation level at each follow-up visit</p><br>