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

Bilateral Ovarian Disease Clinical Trial

Official title:

A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00544310
• Other study ID #: AA-GYN-001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 15, 2007
• Last updated: August 19, 2008
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2008
• Source: OMRIX Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: October 2008
• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bilateral Ovarian Disease
• Ovarian Diseases

Intervention

Biological:
• Anti adhesion agent
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,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries