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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

80 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Semikal Technology

Lead sponsor

Antalya Training and Research Hospital

Collaborator