Lung CancerNCT03623958
Image Guided VATS vs. VATS Resection
A study testing Image guided Video-Assisted Thoracic Surgery (VATS) resection and Video-Assisted Thoracic Surgery in people with Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Image guided Video-Assisted Thoracic Surgery (VATS) resection and Video-Assisted Thoracic Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Raphael Bueno, MD, 617-732-5004, rbueno@bwh.harvard.edu
Julianne Barlow, 617-525-8704, jbarlow1@bwh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Image guided Video-Assisted Thoracic Surgery (VATS) resection, Video-Assisted Thoracic Surgery
- Keywords
- image guided, lung nodule, lung cancer, lung mass
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Video-Assisted Thoracic SurgeryProcedure or surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Video-Assisted Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Room Time
The time (in min.) from incision to close
Measured: 3 years to complete
Secondary outcomes (4)
Time to T-bar placement
The time from patient ready for surgery to placement of t-bar
Measured: 3 years
Time for induction to incision
Time (in min) from induction to incision made
Measured: 3 years
Hospital Length of Stay
Length of hospital stay (in days) in both arms
Measured: 3 years
Radiation Exposure
The radiation exposure (mSV) in the iVATS arm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start11 Sep 2018
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Bueno, Brigham and Women's Hospital
- Investigators
- Raphael Bueno, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623958
- Sponsor's protocol ID
- 2017P000291
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2018
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 26031893
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided VATS Resection vs. VATS Resection of Lung Lesions
- ClinicalTrials.gov ID
- NCT03623958
- Acronym / sponsor ID
- 2017P000291
- Conditions
- Lung Cancer
- Keywords
- image guided, lung nodule, lung cancer, lung mass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iVATS resection | Experimental | Device: Image guided Video-Assisted Thoracic Surgery (VATS) resectionImage guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy. |
| Standard VATS resection | Active comparator | Procedure: Video-Assisted Thoracic SurgeryStandard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image guided Video-Assisted Thoracic Surgery (VATS) resectionImage 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 | Device | iVATS resection |
| Video-Assisted Thoracic SurgeryStandard of Care Video-Assisted Thoracic Surgery (VATS) resection | Procedure or surgery | Standard VATS resection |
Primary outcome
Operating Room Time
Time frame: 3 years to complete
The time (in min.) from incision to close
4 secondary outcomes
Time to T-bar placement
Time frame: 3 years
Time for induction to incision
Time frame: 3 years
Hospital Length of Stay
Time frame: 3 years
Radiation Exposure
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Results publication: PubMed 26031893Gill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphael Bueno, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided Video-Assisted Thoracic Surgery (VATS) resection and Video-Assisted Thoracic Surgery in people with Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julianne S Barlow (617-525-8704, jbarlow1@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating Room Time (time frame: 3 years to complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.