Continuing Evaluation of the LungPoint ATV System

Lung Cancer Clinical Trial

Official title:

Continuing Evaluation of the LungPoint ATV System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02130128
• Other study ID #: Protocol 42
• Status: Terminated
• Phase: N/A
• First received: April 28, 2014
• Last updated: June 3, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Broncus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• LungPoint ATV System
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.

Locations

Country	Name	City	State
Germany	Thoraxklinik	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Broncus Medical Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No