NCT06037837

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
enrolling by invitation

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 Progress90%
Aug 2023Aug 2026

Study Start

First participant enrolled

August 24, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2026

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

August 25, 2023

Last Update Submit

May 16, 2025

Conditions

Keywords

Robot assisted surgical procedurerobotic surgeryprostate surgerykidney surgerybladder surgerycolon surgerypancreas surgerygallbladder surgerystomach surgeryuterus surgerylung surgeryMemorial Sloan Kettering Cancer Center23-094

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Robotic surgeons

Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery

Procedure: Robotic Surgery

Interventions

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

Robotic surgeons

Eligibility Criteria

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

Surgeons who meet the inclusion criteria will be approached by the study team for participation in this study.

You may qualify if:

  • 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

You may not qualify if:

  • Surgeons who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

Location

Related Links

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Alvin Goh, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 14, 2023

Study Start

August 24, 2023

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

August 24, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations