Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Omrix Biopharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Bilateral Ovarian Disease

Treatments

Biological: Anti adhesion agent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00544310

AA-GYN-001

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.