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NCT06037837 Clinical Trial

Improving Surgeon Performance Measures for Robot-Assisted Surgery

Surgery Clinical Trial

Official title:
Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06037837
Other study ID # 23-094
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 24, 2023
Est. completion date August 24, 2026

Study information
Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date August 24, 2026
Est. primary completion date August 24, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Surgeons who perform robotic surgery for candidate procedures - Surgeons who perform candidate procedures that are frequently performed by at least three surgeons (to ensure the ability to make adequate comparisons) - Surgeons who agree to participate in the study Exclusion Criteria: - Surgeons who decline to participate in the study

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Robotic Surgery
Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.

Locations
Country Name City State
United States Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited protocol activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All protocol activites) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activites) Rockville Centre New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of Automated Performance Metrics to surgeon experience For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.
APMs that will be used in the study:
Time Metrics
Camera Metrics
Instrument Metrics
System Metrics
Articulation Metrics		 Up to 2 years
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