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| Sponsored by: |
American Medical Systems |
|---|---|
| Information provided by: | American Medical Systems |
| ClinicalTrials.gov Identifier: | NCT00388947 |
Purpose
Observational (meaning that we are simply collecting whatever information the surgeon typically collects when they see their patients; there is no change to the care the patient receives as a result of being part of the registry) data collection on the surgical outcomes of AMS prolapse products; we predict that patients will be significantly improved as a result of the surgery.
| Condition | Intervention |
|---|---|
|
Vaginal Prolapse |
Device: AMS Prolapse Products (ex: Perigee, Apogee, Straight-In) |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Prolapse Registry: A Prospective Observational Study of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse |
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2008 |
The Prolapse Registry is an observational study of patients who are implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry will follow patients post-operatively for up to 2 years and will collect demographic, clinical, surgical, safety, and patient outcomes data.
The registry is a web-based system in which surgeons enter patient information with regard to their prolapse surgery. All information entered is de-identified (no names, no date of birth, no date of surgery, etc).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Deborah Strohmeyer, MS | 952-930-6061 | Deborah.Strohmeyer@ammd.com |
| United States, Massachusetts | |
| Samuel Zylstra, MD | Recruiting |
| Whitinsville, Massachusetts, United States, 01588 | |
| Contact: Samuel Zylstra, MD 508-234-6260 szylstra@milreg.org | |
| Principal Investigator: | Samuel Zylstra, MD | Whitinsville Medical Center |
More Information
| Responsible Party: | AMS ( Deborah Strohmeyer, Clinical Study Coordinator ) |
| Study ID Numbers: | 1012 |
| Study First Received: | October 16, 2006 |
| Last Updated: | February 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00388947 |
| Health Authority: | United States: Institutional Review Board |
|
vaginal prolapse cystocele rectocele |
enterocele apical prolapse vaginal vault prolapse |
|
Pathological Conditions, Anatomical Rectocele Cystocele Uterine Prolapse Gastrointestinal Diseases Urinary Bladder Diseases Uterine Diseases |
Intestinal Diseases Prolapse Rectal Diseases Genital Diseases, Female Digestive System Diseases Rectal Prolapse |
