Status:
NOT_YET_RECRUITING
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Lead Sponsor:
Semikal Technology
Collaborating Sponsors:
Antalya Training and Research Hospital
Conditions:
Intrauterine Abnormalities in Infertility
Asherman Syndrome
Eligibility:
FEMALE
18+ years
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 Directiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07160764
Start Date
November 1 2025
End Date
December 31 2025
Last Update
September 8 2025
Active Locations (1)
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1
Antalya Training and Research Hospital Gynecology and Obstetrics Clinic
Antalya, Turkey (Türkiye), 07100