Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures. (ISI-I3DM-01)

February 27, 2026 updated by: Intuitive Surgical

A Retrospective Multicenter Study for Intuitive 3D Models (I3DM), During Simulated Preoperative Surgical Planning for Anatomic Lung Resection and Lower Anterior Resection Procedures

The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Retrospective study evaluating the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • The Feinstein Institutes for Medical Research
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be considered for this study.

Description

Inclusion Criteria:

- DICOM images from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thoracic Group
Anatomic Lung Resection (Segmentectomy or Lobectomy) Procedures
Other: observational study
Observational Study
Colorectal Group
Lower Anterior Resection Procedures
Other: observational study
Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning
Time Frame: 2 months
Surgeon questionnaires evaluating their preoperative surgical plan
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Actual)

November 9, 2025

Study Completion (Actual)

November 9, 2025

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-I3DM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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