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Clinical Trials/NCT06434727
NCT06434727
Completed
N/A

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

Intuitive Surgical7 sites in 1 country80 target enrollmentSeptember 30, 2024

Overview

Phase
N/A
Intervention
observational study
Conditions
Thoracic
Sponsor
Intuitive Surgical
Enrollment
80
Locations
7
Primary Endpoint
Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2024
End Date
November 9, 2025
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Arms & Interventions

Colorectal Group

Lower Anterior Resection Procedures

Intervention: observational study

Thoracic Group

Anatomic Lung Resection (Segmentectomy or Lobectomy) Procedures

Intervention: observational study

Outcomes

Primary Outcomes

Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning

Time Frame: 2 months

Surgeon questionnaires evaluating their preoperative surgical plan

Study Sites (7)

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