Back to resultsPilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
Primary Purpose
Bilateral Ovarian Disease
Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Anti adhesion agent
Sponsored by
About this trial
This is an interventional prevention trial for Bilateral Ovarian Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Post surgery adhesion prevention treatment
Outcomes
Primary Outcome Measures
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
Secondary Outcome Measures
Full Information
NCT ID
NCT00544310
First Posted
October 15, 2007
Last Updated
August 19, 2008
Sponsor
OMRIX Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00544310
Brief Title
Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
Official Title
A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
OMRIX Biopharmaceuticals
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Ovarian Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Post surgery adhesion prevention treatment
Intervention Type
Biological
Intervention Name(s)
Anti adhesion agent
Other Intervention Name(s)
Adhexil
Intervention Description
Adhesions prevention
Primary Outcome Measure Information:
Title
Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
New York
State/Province
New York
Country
United States
City
Duisburg
Country
Germany
City
Valencia
Country
Spain
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
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