Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion

Not yet recruiting

• Conditions: Intrauterine Abnormalities in Infertility; Asherman's Syndrome; Asherman Syndrome; Intra-uterine Adhesions; Postoperative Adhesion of Uterus

• Registration Number: NCT07160764
• Lead Sponsor: Semikal Technology

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-15
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy	6 months	Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy

Secondary Outcome Measures

Name	Time	Method
Improvement in menstrual pattern	6 months	from baseline to second look hysteroscopy
Adverse events	through study completion	Incidence and severity of the adverse events associated with adhesion barrier use

Trial Locations

Locations (1)

Antalya Training and Research Hospital Gynecology and Obstetrics Clinic; Antalya, Turkey (Türkiye)