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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Improvement in menstrual pattern
from baseline to second look hysteroscopy
Adverse events
Incidence and severity of the adverse events associated with adhesion barrier use
Sponsors and contacts
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Semikal Technology
Lead sponsor
Antalya Training and Research Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: