Bilateral Ovarian Disease
Conditions
Brief summary
The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Detailed description
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.
Interventions
BIOLOGICALAnti adhesion agent
Adhesions prevention
Sponsors
OMRIX Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-45 years at screening * Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease
Exclusion criteria
* Pregnant (including ectopic pregnancy) or breastfeeding patient * Patients with a documented diagnosis of cancer * Patients with a lymphatic, hematologic or coagulation disorder * Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™ * Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. * Patients who have participated in another clinical study within 30 days of enrolment. * Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries | — |
Countries
Germany, Spain, United Kingdom, United States
Outcome results
None listed