Adhesions, Endometriosis, Ovarian Cysts
Conditions
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.
Interventions
BIOLOGICALADHEXIL
Adhesions prevention
Sponsors
OMRIX Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesions will be assessed according to incidence, extent and severity. | 8 weeks post surgery |
Countries
Germany, Mexico, Russia, Spain, United States
Outcome results
None listed