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OpenTrials
Completed

NCT Number: NCT06896084

Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics

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.

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Key information

Conditions

Health Services Research

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

About this study

The study design is a non-randomized parallel group study in which a group of surgeons (Group A) will make determinations as to the material within each of four visually identical balloons that contain air, water, petroleum jelly or a firm substance similar to the consistency of a non-ripe banana using their hands and eyes while another group of experienced robotic surgeons (Group B) will do so using the da Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).

Before making their "hands on" determinations as to balloon contents, each participant will be asked to first determine whether they can visually determine the balloon contents without any manipulation. For the purposes of outcome measurement, only two possible outcomes are considered - namely that the 4 balloons are ordered correctly or not.

Investigators will also record each "guess" for all participants in order to report any trends of mis-assortment that may occur.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board Certified Surgeon
  • Robotic Board Certified Surgeon

Exclusion criteria

  • Non Board Certified Surgeon

Treatment and study plan

da Vinci Xi System

Device

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

Primary outcomes

  1. Number of participants with Farrington-Manning test of Binary Non-Inferiority

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Valley Health System

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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