Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intrauterine Abnormalities in Infertility, Asherman Syndrome, Intra-uterine Adhesions, Postoperative Adhesion of Uterus. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy [Time frame: 6 months]
Secondary outcome measures (2)
- Improvement in menstrual pattern [Time frame: 6 months]
- Adverse events [Time frame: through study completion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Antalya Training and Research Hospital Gynecology and Obstetrics Clinic — Antalya
Identifiers
NCT: NCT07160764 · SEMFERTIL