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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


Phase 3
18 Years
45 Years
Not Enrolling
Female
Ovarian Cysts, Endometriosis, Adhesions

Thank you

Trial Information

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
tube.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Adhesions will be assessed according to incidence, extent and severity.

Outcome Time Frame:

8 weeks post surgery

Safety Issue:

No

Principal Investigator

Eran Kurman, B.med.Sc, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

OMRIX Biopharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

AA-GYN-002

NCT ID:

NCT00865488

Start Date:

May 2009

Completion Date:

April 2010

Related Keywords:

  • Ovarian Cysts
  • Endometriosis
  • Adhesions
  • Tissue Adhesions
  • Endometriosis
  • Ovarian Cysts

Name

Location

McLean, Virginia  22101