Image Guided VATS vs. VATS Resection

November 12, 2025 updated by: Raphael Bueno, Brigham and Women's Hospital

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject must be 18 years and older
  • Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon
  • Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm
  • Subject's lesions that are located in the outer half portion of the lung/lobe.
  • Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics

Exclusion Criteria:

  • If participant is a pregnant woman or breast feeding they will not be eligible.
  • If treating thoracic surgeon deems the participant not eligible for the study.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iVATS resection
Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection
Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed
Active Comparator: Standard VATS resection
Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.
Procedure: Video-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating Room Time
Time Frame: 3 years to complete
The time (in min.) from incision to close
3 years to complete

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to T-bar placement
Time Frame: 3 years
The time from patient ready for surgery to placement of t-bar
3 years
Time for induction to incision
Time Frame: 3 years
Time (in min) from induction to incision made
3 years
Hospital Length of Stay
Time Frame: 3 years
Length of hospital stay (in days) in both arms
3 years
Radiation Exposure
Time Frame: 3 years
The radiation exposure (mSV) in the iVATS arm
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Analysis of CT scans
Time Frame: 3 years
To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.
3 years

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Raphael Bueno, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 11, 2018

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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