Safety and Performance of the Semical Adhesion Barrier Ge... | NCT07160764

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Aug 15, 2025

First Submission Date that Met QC Criteria

Sep 1, 2025

First Posted Date

Sep 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2025

Last Update Posted Date

Sep 8, 2025Actual

Name	Class
Antalya Training and Research Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cross-linked hyaluronic acid based adhesion barrier gel		Operative hysteroscopy plus adhesion barrier gel
Control group (none)		Operative hysteroscopy alone as control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Improvement in menstrual pattern	from baseline to second look hysteroscopy	6 months
Adverse events	Incidence and severity of the adverse events associated with adhesion barrier use

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

biological females

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aslıhan Kara Study Director	Contact	+90 246 237 01 01		info@semical.com.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antalya Training and Research Hospital Gynecology and Obstetrics Clinic		Antalya		07100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not allowed by locak regulations

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases