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.
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.
Study Type
OBSERVATIONAL
Enrollment
80
Antalya Training and Research Hospital Gynecology and Obstetrics Clinic
Antalya, Turkey (Türkiye)
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy
Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy
Time frame: 6 months
Improvement in menstrual pattern
from baseline to second look hysteroscopy
Time frame: 6 months
Adverse events
Incidence and severity of the adverse events associated with adhesion barrier use
Time frame: through study completion
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