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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Semikal Technology

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Antalya Training and Research Hospital Gynecology and Obstetrics Clinic

Antalya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aslıhan Kara Study Director

Role: CONTACT

+90 246 237 01 01

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Burak Karadağ Prof.Dr

Role: primary

0090 242 249 44 00

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SEMFERTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Esmya Versus Surgery Before IVF/ICSI
NCT04028986 ACTIVE_NOT_RECRUITING