RECRUITING

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Conditions

Pelvic Organ Prolapse GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh POP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

Quick Facts

Study Start:2021-11-24

Study Completion:2032-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04829058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse 2. GYNEMESH PS Mesh was used as a bridging material according to the IFU. 3. Able and willing to participate in follow-up 4. Subject or authorized representative has signed the approved informed consent 1. Subjects \< 21 years of age at the time of informed consent 2. Subjects who had transvaginal approach for surgery 3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
3. Able and willing to participate in follow-up
4. Subject or authorized representative has signed the approved informed consent
1. Subjects \< 21 years of age at the time of informed consent
2. Subjects who had transvaginal approach for surgery
3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Christine Romanowski

CONTACT

908-808-6219

cromanow@its.jnj.com

Principal Investigator

Martin Weisberg, MD

STUDY_DIRECTOR

Ethicon, Inc.

Study Locations (Sites)

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, 19454

United States

UMPC

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Ethicon, Inc.

Martin Weisberg, MD, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-24

Study Completion Date2032-03-31

Study Record Updates

Study Start Date2021-11-24

Study Completion Date2032-03-31

Terms related to this study

Keywords Provided by Researchers

GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
POP

Additional Relevant MeSH Terms

Pelvic Organ Prolapse