Continuing Evaluation of the LungPoint ATV System

The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Device: 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 safety and yield of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer. Navigation to and sampling of the patient's lung cancer tumor is conducted.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Thoraxklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Surgical candidates age 21-75 years at screening
2. Highly suspicious SPN, defined as distinct nodule with a diameter of 10-30 mm in its largest dimension
3. No known endobronchial tumor
4. Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE.
5. Willing to participate in all aspects of study protocol for duration of study
6. Able to understand study requirements
7. Signs study-related informed consent document

Exclusion Criteria:

1. Any contraindication to bronchoscopy, for example: (a.) Untreatable life-threatening arrhythmias, (b.) Inability to adequately oxygenate the patient during the procedure, (c.) Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated), (d.) Recent myocardial infarction, (e.) Previously diagnosed high-grade tracheal obstruction, (f.) Uncorrectable coagulopathy.
2. Known coagulopathy
3. Platelet dysfunction or platelet count < 100 x 103 cells/mm3
4. History of major bleeding with bronchoscopy
5. Pulmonary hypertension with mean PAP >25 mm
6. Moderate-to-severe pulmonary fibrosis
7. Moderate to severe emphysema or COPD with FEV1 <60% predicted or RV >200% predicted
8. Bullae >5 cm located in vicinity of target SPN or ATV tunnel
9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example: (a.) ASA class > 3, (b.) > stage 3 heart failure, (c.) severe cachexia, (d.) severe respiratory insufficiency or hypoxia
10. Ongoing systemic infection
11. Contraindication to general anesthesia
12. Chronic use of anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel)
13. Participation in any other study in last 30 days
14. Prior thoracic surgery on the same side of the lung as the SPN
15. Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
16. Life expectancy of less than one year.
17. Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors
18. Scheduled for lung surgery within 7 days post-scheduled diagnostic bronchoscopy

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Navigation and tissue sampling; Guided bronchoscopic navigation and lung tissue sampling using the LungPoint ATV System	Device: LungPoint ATV System; The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of serious adverse events	The number of serious adverse events (SAEs) rated as probably or definitely related to the study device and/or procedure divided by the number of patients in whom an attempt at study device use was made. This study protocol focuses specifically on sub-chronic pneumothorax, but will also track hemoptysis.	Up to 24 hours post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of biopsies yielding tissue sufficient for diagnosis	The number of nodules with at least one biopsy sufficient for a tissue diagnosis divided by the number of nodules sampled by the LP ATV System.	Upon asssessment of histology of tissue sample taken during procedure

Collaborators and Investigators

• Sponsor: Broncus Medical Inc

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (ESTIMATE): May 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Protocol 42