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Uphold LITE Post-Market Surveillance Study

NCT01917968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2021-05-20

Study results available
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Summary

The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Uphold Lightweight Vaginal Support System

Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)

PROCEDURE

Traditional native tissue repair

Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Karen Noblett, MD · University of California, Irvine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-10
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917968 on ClinicalTrials.gov