Trial Outcomes & Findings for Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions (NCT NCT01847209)

NCT ID: NCT01847209

Last Updated: 2025-11-18

Results Overview

The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-11-18

Participant Flow

The recruitment for this study was completed in the medical clinic and started in April 2013 and included in September 2014.

Participant milestones

Measure	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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Overall Study Withdrawal by Subject	1
Overall Study No lung nodule found on intraop CT scan	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CT Marking and VATS Lung Wedge Resection n=23 Participants 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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Age, Categorical <=18 years	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=23 Participants
Age, Categorical >=65 years	11 Participants n=23 Participants
Age, Continuous	65 Years n=23 Participants
Sex: Female, Male Female	16 Participants n=23 Participants
Sex: Female, Male Male	7 Participants n=23 Participants
Region of Enrollment United States	23 Participants n=23 Participants

PRIMARY outcome

Timeframe: 30 days

The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.

Outcome measures

Measure	CT Marking and VATS Lung Wedge Resection n=23 Participants 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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	1 Participants

SECONDARY outcome

Timeframe: 30 days

Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline

Outcome measures

Measure	CT Marking and VATS Lung Wedge Resection n=23 Participants 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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Patients Underwent a Successful Resection	23 Participants

Adverse Events

CT Marking and VATS Lung Wedge Resection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CT Marking and VATS Lung Wedge Resection n=23 participants at risk 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. Video-Assisted Thoracic Surgery (VATS) wedge resection
Surgical and medical procedures Received increased radiation dose	4.3% 1/23 • Number of events 1 • 1 year from consent and surgery

Additional Information

Dr. Raphael Bueno

Brigham and Women's Hospital

Phone: 617-732-8148

Email: rbueno@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place