Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Lung Cancer Clinical Trial

Official title:

Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847209
• Other study ID #: 2012P001915
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• peripheral lung nodules < 3cm in size

• Surgical candidate

Exclusion Criteria:

• Non surgical candidate

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Video-Assisted Thoracic Surgery (VATS) wedge resection

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Siemens Medical Solutions USA - CSG

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	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.	30 days
Secondary	Patients Underwent a Successful Resection	Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline	30 days