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

Primary Purpose

Ovarian Cysts, Endometriosis, Adhesions

Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ADHEXIL
Sponsored by
OMRIX Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Cysts

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

patients who will be treated in accordance with standard of care

patients for which Adhexil will be applied to prevent/reduce adhesions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 18, 2009
Last Updated
December 20, 2009
Sponsor
OMRIX Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00865488
Brief Title
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Suspended
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
OMRIX Biopharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts, Endometriosis, Adhesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
patients who will be treated in accordance with standard of care
Arm Title
2
Arm Type
Experimental
Arm Description
patients for which Adhexil will be applied to prevent/reduce adhesions
Intervention Type
Biological
Intervention Name(s)
ADHEXIL
Intervention Description
Adhesions prevention
Primary Outcome Measure Information:
Title
Adhesions will be assessed according to incidence, extent and severity.
Time Frame
8 weeks post surgery

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Kurman, B.med.Sc, MBA
Organizational Affiliation
OMRIX Biopharmaceuticals
Official's Role
Study Chair
Facility Information:
City
Richmond
State/Province
Virginia
Country
United States
City
Duisburg
Country
Germany
City
Mexico City
Country
Mexico
City
Moscow
Country
Russian Federation
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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