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SUSPENDEDPhase 3NCT00865488

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

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.

Lead sponsor: OMRIX Biopharmaceuticals•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

OMRIX Biopharmaceuticals

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.

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 23, 2009Terms

Trial snapshot

StatusSUSPENDED

PhasePHASE3

Enrollment80

Start dateMay 2009

Last updatedDec 23, 2009

Condition

Ovarian Cysts Endometriosis Adhesions

Locations shown

Richmond, Virginia

Duisburg

Mexico City

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2009Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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