NCT01134003

Brief Summary

retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

1.8 years

First QC Date

May 27, 2010

Last Update Submit

May 28, 2010

Conditions

Keywords

Gynecare ProliftPelvic organ prolapseforming a large database of women who have recieve Gynecare prolift system

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

You may qualify if:

  • women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 31, 2010

Study Start

January 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations