LungPoint ATV for Biopsy in Patients Undergoing Lobectomy

NCT ID: NCT02130115

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

LungPoint ATV System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Surgical candidates age 21-75 years at screening

2. Known or suspected lung cancer or intrapulmonary metastatic disease with SPN greater than 10 mm and less than 40mm in 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broncus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix Herth, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Thoraxklinik

Heidelberg, , Germany

Countries

Germany

References

Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015 Apr;70(4):326-32. doi: 10.1136/thoraxjnl-2014-206211. Epub 2015 Mar 6.

Reference Type: DERIVED

PMID: 25746631 (View on PubMed)

Other Identifiers

Protocol 40

Identifier Type: -

Identifier Source: org_study_id