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Sponsored by: |
Ethicon, Inc. |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00521066 |
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.
(*TRADEMARK)
Condition | Intervention |
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Pelvic Organ Prolapse |
Device: GYNECARE PROSIMA* Pelvic Floor Repair System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multi-Centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse |
Estimated Enrollment: | 160 |
Study Start Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judith Gauld, BSc (Hons) | +44 150 659 4679 | jgauld@ethgb.jnj.com |
United States, Florida | |
Specialists in Urology | Recruiting |
Naples, Florida, United States, 34102 | |
United States, Michigan | |
Female Pelvic Medicine and Urogynecology Institute of Michigan | Recruiting |
Dearborn, Michigan, United States, 48124 | |
Recruiting | |
Grand Rapids, Michigan, United States, 49506 | |
United States, Pennsylvania | |
Magee Women's Hospital of the Universtiy of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
The Institute for Female Pelvic Medicine & Reconstructive Surgery | Recruiting |
Allentown, Pennsylvania, United States, 18104 | |
Australia | |
Royal Women's Hospital | Recruiting |
Melbourne, Australia, 3053 | |
Germany | |
Universitatsklinik Tubingen | Recruiting |
Tubingen, Germany, 72076 | |
Bereich Urogynakologie | Recruiting |
Halle, Germany, 06097 | |
United Kingdom | |
St. Mary's Hospital | Recruiting |
Manchester, United Kingdom, M13 0JH | |
North Hampshire Hospital | Recruiting |
Hampshire, United Kingdom, RG24 9NA | |
Addendokes Hospital | Recruiting |
Cambridge, United Kingdom, CB2 0QQ |
Study Director: | David Robinson, M.D. | Ethicon, Inc. |
Study ID Numbers: | 300-06-005 |
Study First Received: | August 24, 2007 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00521066 |
Health Authority: | United States: Institutional Review Board; United Kingdom: Research Ethics Committee; Germany: Ethics Commission; Australia: Human Research Ethics Committee |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |