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

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.

Inclusion Criteria:

• Female patients aged 18 and over
• Patients who were treated with operative hysteroscopy for intrauterine pathology (endometrial polips, myomas with uterine cavity deformation, uterine septa, intrauterine adhesion, ovarian cyst, endometrial cyst, etc.)
• Patients who had undergone operative hysteroscopy at least 30 days and at most 6 months ago
• Patients who had second-look office hysteroscopy at least once after an operative hysteroscopy

Exclusion Criteria:

• Children and adolescents under 18 years of age
• Having a body weight of more than 100 kg
• Surgeries complicated by excessive bleeding; estimated blood loss of more than 100 cc
• Surgeries complicated with uterine perforation
• Presence of uncontrolled diabetes, coagulation disorders, and other severe chronic disorders
• Presence of malignant tumor or diagnosis of cancer, presence of uterovaginal prolapse
• Concomitant peritoneal grafting or tubal implantation
• Concomitant intrauterine device implantation
• Patients without second-look hysteroscopy

According to the GDPR and clinical investigation legislation, written informed consent is not mandatory in retrospective studies as long as the patient's personal information is censored.