Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

NCT ID: NCT01847209

Last Updated: 2025-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-09-30

Brief Summary

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This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.

Detailed Description

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This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT Marking and VATS lung wedge resection

Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.

Group Type EXPERIMENTAL

Video-Assisted Thoracic Surgery (VATS) wedge resection

Intervention Type PROCEDURE

Interventions

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Video-Assisted Thoracic Surgery (VATS) wedge resection

Intervention Type PROCEDURE

Other Intervention Names

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Nodules marked with fiducials such as Kopan needles under CT fluoroscopy followed by VATS wedge resection.

Eligibility Criteria

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Inclusion Criteria

* peripheral lung nodules \< 3cm in size
* Surgical candidate

Exclusion Criteria

* Non surgical candidate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Medical Solutions USA - CSG

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raphael Bueno

Associate Chief of Thoracic Surgery; Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael Bueno, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

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 BACKGROUND
PMID: 26031893 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2012P001915

Identifier Type: -

Identifier Source: org_study_id

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