Continuing Evaluation of the LungPoint ATV System

NCT02130128 | Terminated

• 1 other identifier: Protocol 42
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of biopsies yielding tissue sufficient for diagnosis

  Upon asssessment of histology of tissue sample taken during procedure

Study Arms (1)

Navigation and tissue sampling

EXPERIMENTAL

Guided bronchoscopic navigation and lung tissue sampling using the LungPoint ATV System

Device: LungPoint ATV System

Interventions

LungPoint ATV System DEVICE

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

Navigation and tissue sampling

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Known coagulopathy
• Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
• History of major bleeding with bronchoscopy
• Pulmonary hypertension with mean PAP \>25 mm
• Moderate-to-severe pulmonary fibrosis
• Moderate to severe emphysema or COPD with FEV1 \<60% predicted or RV \>200% predicted
• Bullae \>5 cm located in vicinity of target SPN or ATV tunnel
• 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
• Ongoing systemic infection
• Contraindication to general anesthesia
• Chronic use of anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel)
• Participation in any other study in last 30 days
• Prior thoracic surgery on the same side of the lung as the SPN
• 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.

Sponsors & Collaborators

• Broncus Medical Inc: lead

Study Sites (1)

Thoraxklinik

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Felix Herth, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

DE (1)