A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:
⁃ Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
• Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
• GYNEMESH PS Mesh was used as a bridging material according to the IFU.
• Able and willing to participate in follow-up
• Subject or authorized representative has signed the approved informed consent
Locations
United States
Pennsylvania
Institute for Female Pelvic Medicine
RECRUITING
North Wales
UMPC
RECRUITING
Pittsburgh
Other Locations
Germany
Universitatsklinikum Tubingen
RECRUITING
Tübingen
Contact Information
Primary
Christine Romanowski
cromanow@its.jnj.com
908-808-6219
Time Frame
Start Date: 2021-11-24
Estimated Completion Date: 2032-03-31
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Ethicon, Inc.