NCT02130115

LungPoint ATV for Biopsy in Patients Undergoing Lobectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Broncus Medical Inc · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System.

Detailed description

The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. This feasibility study is being conducted to assess the ability of the investigator to access and sample tissue using this system in patients undergoing lobectomy or pneumonectomy. Navigation to and sampling of the patient's lung cancer tumor is conducted immediately prior to the scheduled lobectomy or pneumonectomy. Note: This study was conducted as a single-center feasibility clinical trial to determine the feasibility of this device. The primary outcome measures related only to feasibility and not to health outcomes. Therefore it was not registered on clinicaltrials.gov prior to the start of enrollment. Subsequently, it was determined that the results were compelling and therefore it was registered to facilitate publication.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	LungPoint ATV System	The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2014-05-05
• Last updated: 2014-05-05

Locations

1 site across 1 country: Germany