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NCT06434727 Clinical Trial

Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.

Colorectal Disorders Clinical Trial

— ISI-I3DM-01  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06434727
Other study ID # ISI-I3DM-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date December 2024

Study information
Verified date May 2024
Source Intuitive Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: DICOM inages from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be . Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Intuitive Surgical

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning Surgeon questionnaires evaluating their preoperative surgical plan 2 months
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