NCT00544310

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

First QC Date

October 15, 2007

Last Update Submit

August 19, 2008

Conditions

Bilateral Ovarian Disease

Outcome Measures

Primary Outcomes (1)

  • Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries

Study Arms (1)

1

EXPERIMENTAL

Post surgery adhesion prevention treatment

Biological: Anti adhesion agent

Interventions

Anti adhesion agentBIOLOGICAL

Adhesions prevention

Also known as: Adhexil
1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients aged 18-45 years at screening
  • Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Duisburg, Germany

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Oxford, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

January 1, 2008

Study Completion

October 1, 2008

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

US(1)GB(1)ES(1)DE(1)