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

NCT07160764 | Not Yet Recruiting

• 1 other identifier: SEMFERTIL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

intrauterine abnormalities; asherman's syndrome; intrauterine adhesions; postoperative adhesions

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy

  Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy

  6 months

Secondary Outcomes (2)

• Improvement in menstrual pattern

  6 months

• Adverse events

  through study completion

Study Arms (2)

Cross-linked hyaluronic acid based adhesion barrier gel

Operative hysteroscopy plus adhesion barrier gel

Control group (none)

Operative hysteroscopy alone as control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients ages 18 years and over who are at risk of postoperative adhesion formation after operative hysteroscopy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semikal Technology: lead
• Antalya Training and Research Hospital: collaborator

Study Sites (1)

Antalya Training and Research Hospital Gynecology and Obstetrics Clinic

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Aslıhan Kara Study Director

CONTACT

+90 246 237 01 01; info@semical.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 8, 2025
• Study Start: November 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)