Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
NCT ID: NCT07160764
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2025-11-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cross-linked hyaluronic acid based adhesion barrier gel
Operative hysteroscopy plus adhesion barrier gel
No interventions assigned to this group
Control group (none)
Operative hysteroscopy alone as control group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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Antalya Training and Research Hospital
OTHER_GOV
Semikal Technology
INDUSTRY
Responsible Party
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Locations
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Antalya Training and Research Hospital Gynecology and Obstetrics Clinic
Antalya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Burak Karadağ Prof.Dr
Role: primary
Other Identifiers
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SEMFERTIL
Identifier Type: -
Identifier Source: org_study_id
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