Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment video-assisted thoracic surgery (vats) wedge resection
Phase phase 2
Sponsor Brigham and Women's Hospital
Collaborator Siemens Medical Solutions USA - CSG
Start date April 2013
End date September 2014
Trial size 25 participants
Trial identifier NCT01847209, 2012P001915

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Nodules marked with fiducials such as Kopan needles under CT fluoroscopy followed by VATS wedge resection.

Primary Outcomes

Measure
Safety
time frame: 30 days

Secondary Outcomes

Measure
Efficacy
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - peripheral lung nodules < 3cm in size - Surgical candidate Exclusion Criteria: - Non surgical candidate

Additional Information

Official title Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Principal investigator Raphael Bueno, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.