NCT06434727

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2025

Completed
Last Updated

March 3, 2026

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

May 23, 2024

Last Update Submit

February 27, 2026

Conditions

ThoracicColorectal Disorders

Outcome Measures

Primary Outcomes (1)

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

    Surgeon questionnaires evaluating their preoperative surgical plan

    2 months

Study Arms (2)

Thoracic Group

Anatomic Lung Resection (Segmentectomy or Lobectomy) Procedures

Other: observational study

Colorectal Group

Lower Anterior Resection Procedures

Other: observational study

Interventions

observational studyOTHER

Observational Study

Colorectal GroupThoracic Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

September 30, 2024

Primary Completion

November 9, 2025

Study Completion

November 9, 2025

Last Updated

March 3, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)