Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
Phase 3
Suspended
- Conditions
- Ovarian CystsEndometriosisAdhesions
- Registration Number
- NCT00865488
- Lead Sponsor
- OMRIX Biopharmaceuticals
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
- Detailed Description
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 tube.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- Female patients aged 18-45 years at screening.
- Patients undergoing elective laparoscopic surgery involving at least one adnexa.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adhesions will be assessed according to incidence, extent and severity. 8 weeks post surgery
- Secondary Outcome Measures
Name Time Method