NCT02367235

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

3.2 years

First QC Date

December 9, 2014

Last Update Submit

April 25, 2018

Conditions

Pelvic Organ Prolapse

Keywords

roboticsacrocolpopexyColpassistvaginal positioning device

Outcome Measures

Primary Outcomes (1)

  • Comparison of duration of surgical steps during sacral colpopexy

    Length of time will be recorded for each step of the sacral colpopexy that utilizes the vaginal positioning device (dissection of anterior vaginal wall, dissection of posterior vaginal wall, attachment of anterior vaginal mesh, attachment of posterior vaginal mesh, and attachment of sacral mesh) during the surgery. No follow up will be required by the patient.

    Intraoperative

Secondary Outcomes (1)

  • Surgeon and surgical-assistant satisfaction with the device

    On the day of surgery

Study Arms (2)

Traditional vaginal positioning device

EXPERIMENTAL

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed endo anal sizer.

Procedure: Traditional vaginal positioning device

Colpassist vaginal positioning device

EXPERIMENTAL

Patients will undergo their robotic-assisted sacrocolpopexy using a vaginally placed Colpassist vaginal manipulator.

Procedure: Colpassist vaginal positioning device

Interventions

Traditional vaginal positioning devicePROCEDURE

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

Traditional vaginal positioning device
Colpassist vaginal positioning devicePROCEDURE

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

Colpassist vaginal positioning device

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years old
  • Planned robotic-assisted sacrocolpopexy
  • English speaking
  • Prior hysterectomy (either total or supra-cervical)

You may not qualify if:

  • Age less than 18 years old
  • Non-English speaking
  • Pregnant women, or women desiring future pregnancy
  • Planned concomitant hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina, Chapel Hill - Female Pelvic Medicine and Reconstructive Surgery

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Geller, MD

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

February 20, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 27, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)