Trials / Not Yet Recruiting
Not Yet RecruitingNCT07160764
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Evaluation of Performance and Safety of Hyalosem Cross-linked Hyaluronic Acid Adhesion Barrier Gel in Preventing Intra-uterine Adhesion Formation After Operative Hysteroscopy: A Retrospective Study
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (estimated)
- Sponsor
- Semikal Technology · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation.
Detailed description
This study was designed as a non-interventional (observational), comparative, retrospective and single-center study. The investigational device has the CE mark under 93/42/ EEC Medical Device Directive and is used in accordance with the intended use declared by the manufacturer in the user manual. Therefore, the study is a post-marketing clinical follow-up (PMCF) study.
Conditions
- Intrauterine Abnormalities in Infertility
- Asherman Syndrome
- Intra-uterine Adhesions
- Postoperative Adhesion of Uterus
- Asherman's Syndrome
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2025-09-08
- Last updated
- 2025-09-08
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07160764. Inclusion in this directory is not an endorsement.