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

Semikal Technology

Status

Not yet enrolling

Conditions

Asherman's Syndrome

Postoperative Adhesion of Uterus

Intra-uterine Adhesions

Asherman Syndrome

Intrauterine Abnormalities in Infertility

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07160764

SEMFERTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.