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Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery | Clinical Trials | Clareo Health

SUSPENDEDPHASE3

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

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

NCT00865488•OMRIX Biopharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

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.

Locations (5)

Richmond, Virginia, United States

Duisburg, Germany

Mexico City, Mexico

Moscow, Russia

Valencia, Spain

Key Dates

Start Date

May 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

April 1, 2010

Last Updated

December 23, 2009

Enrollment

ESTIMATED participants

Conditions

Ovarian CystsEndometriosisAdhesions

Interventions

ADHEXIL

BIOLOGICAL

The Developmental Origins of Endometriosis

NCT05951452

Endometriosis

View study

RECRUITINGPHASE2

Glycemic Regulation as Endometriosis Adjunct Treatment

NCT06611501

Pelvic PainEndometriosis

View study

RECRUITINGNA

Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women

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: March 29, 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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Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

Inclusion Criteria

Exclusion Criteria

The Developmental Origins of Endometriosis

Glycemic Regulation as Endometriosis Adjunct Treatment

Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Effect of Tele-Yoga on Pain, Fatigue, and Quality of Life in Endometriosis

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer