NCT06896084

Brief Summary

The purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

August 31, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

August 19, 2024

Last Update Submit

March 19, 2025

Conditions

Health Services Research

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Farrington-Manning test of Binary Non-Inferiority

    Using the Farrington-Manning test of binary non-inferiority, investigators hypothesize that 100% correct balloon discernment by hands-on surgeons and prospectively set 80% correct discernment by robotic surgeons as their definition of non-inferiority. A correct response is a binary outcome for each of the four balloons.

    1 month

Study Arms (2)

Group A

Board Certified Surgeons

Device: da Vinci Xi System

Group B

Robotic Board Certified Surgeons

Device: da Vinci Xi System

Interventions

da Vinci Xi SystemDEVICE

A group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Targeted population are board certifed surgeons and those who are robotic certified surgeons

You may qualify if:

  • Board Certified Surgeon
  • Robotic Board Certified Surgeon

You may not qualify if:

  • Non Board Certified Surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

March 26, 2025

Study Start

August 31, 2023

Primary Completion

May 31, 2024

Study Completion

August 9, 2024

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations

US(1)