Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

Omrix Biopharmaceuticals

Status and phase

Suspended

Phase 3

Conditions

Adhesions

Ovarian Cysts

Endometriosis

Treatments

Biological: ADHEXIL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00865488

AA-GYN-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

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 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.