A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
Patients will be divided into two arms: 1) patients who will be treated in accordance with
standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian
- Female patients aged 18-45 years at screening.
- Patients undergoing elective laparoscopic surgery involving at least one adnexa.
- 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Adhesions will be assessed according to incidence, extent and severity.
Outcome Time Frame:
8 weeks post surgery
Eran Kurman, B.med.Sc, MBA
United States: Food and Drug Administration
- Ovarian Cysts
- Tissue Adhesions
- Ovarian Cysts
|McLean, Virginia 22101|