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Surgical Outcomes of Vaginal Prolapse Repair With Elevate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Larry Sirls, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01190618
First received: August 26, 2010
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Condition
Vaginal Prolapse

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit

Further study details as provided by Larry Sirls, William Beaumont Hospitals:

Primary Outcome Measures:
  • Comparison of Outcomes [ Time Frame: 3 Months ]
    To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.


Enrollment: 417
Study Start Date: August 2010
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Detailed Description:
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women having vaginal repair with Elevate prolapse repair kit
Criteria

Inclusion Criteria:

  • Women who have had a vaginal repair with Elevate prolapse repair kit

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190618

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Larry Sirls
Investigators
Principal Investigator: Larry Sirls, MD William Beaumont Hospitals
  More Information

Responsible Party: Larry Sirls, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01190618     History of Changes
Other Study ID Numbers: 2010-176
Study First Received: August 26, 2010
Last Updated: February 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 27, 2017