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Study 12 of 594 for search of: | received on or after 01/16/2009 |
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Sponsored by: |
Ethicon, Inc. |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00833001 |
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Condition | Intervention | Phase |
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Cystocele Rectocele Enterocele |
Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System |
Phase II Phase III |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective, Multi-Center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse |
Enrollment: | 126 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
GYNECARE PROLIFT+M* Pelvic Floor Repair System
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Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
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Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Sint Lodewijkstraat 78 | |
Genk, Belgium | |
France | |
CHRU de Lille | |
Lille, France, 59037 | |
Germany | |
St. Marien-Hospital | |
Vechta, Germany, D-49377 | |
Kreiskrankenhaus | |
Hameln, Germany, 31785 | |
Universitatsklinik Tubingen | |
Tubingen, Germany, 72076 | |
Martin Luther University | |
Halle, Germany, 06097 | |
DRT Krankenhaus | |
Chemnitz, Germany, 09034 | |
Netherlands | |
Reinier de Graaf Gasthuis | |
Delft, Netherlands |
Study Director: | David Robinson, MD | Ethicon, Inc. |
Responsible Party: | Ethicon ( David Robinson MD/Medical Director ) |
Study ID Numbers: | 300-07-006 |
Study First Received: | January 26, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00833001 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: German Institute of Medical Documentation and Information; Netherlands: Dutch Health Care Inspectorate |
Anterior vaginal prolapse (medial, lateral,apical cystocele) Posterior vaginal prolapse (rectocele and/or enterocele) Vault prolapse (enterocele, uterine/vaginal vault prolapse) |
Pathological Conditions, Anatomical Rectocele Digestive System Diseases Cystocele Urologic Diseases Gastrointestinal Diseases |
Hernia Urinary Bladder Diseases Intestinal Diseases Rectal Diseases Prolapse Rectal Prolapse |