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Analysis of Procedural Times Using Colpassist for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial

NCT02367235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-04-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning device during robotic-assisted sacrocolpopexy.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Traditional vaginal positioning device

A vaginally placed endo-anal sizer will be used to position the vagina during surgery.

PROCEDURE

Colpassist vaginal positioning device

A vaginally placed Colpassist will be used to position the vagina during surgery.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Intuitive Surgical

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Elizabeth Geller, MD · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-04-30
Completion
2018-04-30

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 NCT02367235 on ClinicalTrials.gov