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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00865488
• Other study ID #: AA-GYN-002
• Status: Suspended
• Phase: Phase 3
• First received: March 18, 2009
• Last updated: December 20, 2009
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: December 2009
• Source: OMRIX Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-InstitutGermany: Ethics CommissionRussia: Ministry of Health of the Russian FederationSpain: Ethics CommitteeSpain: Ministry of HealthMexico: Ministry of HealthMexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adhesions
• Endometriosis
• Ovarian Cysts
• Tissue Adhesions

Intervention

Biological:
• ADHEXIL
Adhesions prevention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OMRIX Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Mexico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesions will be assessed according to incidence, extent and severity.		8 weeks post surgery	No