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Sponsored by: |
Ethicon, Inc. |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00242437 |
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
Condition | Intervention | Phase |
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Sinusitis |
Device: Hemostatic matrix Device: bovine thrombin |
Phase IV |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
The Summit Medical GroupDepartment of Otolaryngology | |
Summit, New Jersey, United States, 07901 | |
United States, South Carolina | |
The Medical University of South Carolina Department of Otolaryngology | |
Charleston, South Carolina, United States, 29425-0550 | |
United States, Tennessee | |
University of Tennessee Department of Otolaryngology | |
Memphis, Tennessee, United States, 38163 |
Study Director: | James Hart, MD | Ethicon, Inc. |
Study ID Numbers: | 400-05-002 |
Study First Received: | October 19, 2005 |
Last Updated: | July 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00242437 History of Changes |
Health Authority: | United States: Institutional Review Board |
Thrombin Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Sinusitis Hemostatics |
Thrombin Otorhinolaryngologic Diseases Coagulants Respiratory Tract Infections Respiratory Tract Diseases Paranasal Sinus Diseases |
Therapeutic Uses Hematologic Agents Sinusitis Pharmacologic Actions Hemostatics Nose Diseases |