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

V

Valley Health System

Status

Completed

Conditions

Health Services Research

Treatments

Device: da Vinci Xi System

Study type

Observational

Funder types

Other

Identifiers

NCT06896084
II_Culligan_24JUN23

Details and patient eligibility

About

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.

Full description

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Board Certified Surgeon
  • Robotic Board Certified Surgeon

Exclusion criteria

• Non Board Certified Surgeon

Trial design

53 participants in 2 patient groups

Group A
Description:
Board Certified Surgeons
Treatment:
Device: da Vinci Xi System
Group B
Description:
Robotic Board Certified Surgeons
Treatment:
Device: da Vinci Xi System

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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