Spots Global Cancer Trial Database for Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
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Trial Identification
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 ID: NCT00865488
Interventions
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, Richmond, Virginia, United States
, Duisburg, , Germany
, Mexico City, , Mexico
, Moscow, , Russian Federation
, Valencia, , Spain
Contact Details
Name: Eran Kurman, B.med.Sc, MBA
Affiliation: OMRIX Biopharmaceuticals
Role: STUDY_CHAIR
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