NCT03623958

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
14mo left

Started Sep 2018

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress87%
Sep 2018Jul 2027

First Submitted

Initial submission to the registry

July 20, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

8.9 years

First QC Date

July 20, 2018

Last Update Submit

November 12, 2025

Conditions

Lung Cancer

Keywords

image guidedlung nodulelung cancerlung mass

Outcome Measures

Primary Outcomes (1)

  • Operating Room Time

    The time (in min.) from incision to close

    3 years to complete

Secondary Outcomes (4)

  • Time to T-bar placement

    3 years

  • Time for induction to incision

    3 years

  • Hospital Length of Stay

    3 years

  • Radiation Exposure

    3 years

Other Outcomes (1)

  • Quantitative Analysis of CT scans

    3 years

Study Arms (2)

iVATS resection

EXPERIMENTAL

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

Standard VATS resection

ACTIVE COMPARATOR

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

Procedure: Video-Assisted Thoracic Surgery

Interventions

Image guided Video-Assisted Thoracic Surgery (VATS) resectionDEVICE

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

iVATS resection
Video-Assisted Thoracic SurgeryPROCEDURE

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

Standard VATS resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26031893RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Raphael Bueno, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianne S Barlow

CONTACT

617-525-8704jbarlow1@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Throacic Surgery

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 9, 2018

Study Start

September 11, 2018

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

November 13, 2025

Record last verified: 2025-11

Locations

US(1)