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NCT Number: NCT03623958

Image Guided VATS vs. VATS Resection

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Image guided Video-Assisted Thoracic Surgery (VATS) resection

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

Video-Assisted Thoracic Surgery

Procedure

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

Primary outcomes

  1. Operating Room Time

    Time frame: 3 years to complete

    The time (in min.) from incision to close

Secondary outcomes

  1. Time to T-bar placement

    Time frame: 3 years

    The time from patient ready for surgery to placement of t-bar

  2. Time for induction to incision

    Time frame: 3 years

    Time (in min) from induction to incision made

  3. Hospital Length of Stay

    Time frame: 3 years

    Length of hospital stay (in days) in both arms

  4. Radiation Exposure

    Time frame: 3 years

    The radiation exposure (mSV) in the iVATS arm

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julianne S Barlow

CONTACT

[email protected]

617-525-8704

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2018
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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