Image Guided VATS vs. VATS Resection

NCT ID: NCT03623958

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Keywords

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image guided lung nodule lung cancer lung mass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iVATS resection

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

Group Type EXPERIMENTAL

Image guided Video-Assisted Thoracic Surgery (VATS) resection

Intervention Type DEVICE

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

Standard VATS resection

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Group Type ACTIVE_COMPARATOR

Video-Assisted Thoracic Surgery

Intervention Type PROCEDURE

Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Interventions

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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

Intervention Type DEVICE

Video-Assisted Thoracic Surgery

Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raphael Bueno

Chief of Throacic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael Bueno, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julianne S Barlow

Role: CONTACT

Phone: 617-525-8704

Email: [email protected]

Facility Contacts

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Raphael Bueno, MD

Role: primary

Julianne Barlow

Role: backup

References

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Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.

Reference Type RESULT
PMID: 26031893 (View on PubMed)

Other Identifiers

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2017P000291

Identifier Type: -

Identifier Source: org_study_id