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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSemikal Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Cross-linked hyaluronic acid based adhesion barrier gel
Group B: Control group (none)

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Improvement in menstrual pattern

from baseline to second look hysteroscopy

Time frame
6 months
2

Adverse events

Incidence and severity of the adverse events associated with adhesion barrier use

Time frame
through study completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semikal Technology

Lead sponsor

Antalya Training and Research Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: