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

• Sponsor: OMRIX Biopharmaceuticals (Industry)
• Overall Status: Suspended
• CT.gov ID: NCT00865488
• Collaborator: (none)
• Enrollment: 80
• Locations: 5
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 16
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cysts; Endometriosis; Adhesions	Biological: ADHEXIL	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: May 1, 2009
• Anticipated Primary Completion Date: Feb 1, 2010
• Anticipated Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 patients who will be treated in accordance with standard of care
Experimental: 2 patients for which Adhexil will be applied to prevent/reduce adhesions	Biological: ADHEXIL; Adhesions prevention

Outcome Measures

Primary Outcome Measures

1. Adhesions will be assessed according to incidence, extent and severity. [8 weeks post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Richmond	Virginia	United States
2		Duisburg		Germany
3		Mexico City		Mexico
4		Moscow		Russian Federation
5		Valencia		Spain

Sponsors and Collaborators

• OMRIX Biopharmaceuticals

Investigators

• Study Chair: Eran Kurman, B.med.Sc, MBA, OMRIX Biopharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00865488
• Other Study ID Numbers: AA-GYN-002
• First Posted: Mar 19, 2009
• Last Update Posted: Dec 23, 2009
• Last Verified: Dec 1, 2009

• Additional relevant MeSH terms: Ovarian Cysts; Endometriosis; Tissue Adhesions

Study Results

No Results Posted as of Dec 23, 2009