NCT02130115

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

April 25, 2014

Last Update Submit

May 2, 2014

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Ability to complete procedure using system

    The proportion of cases (attempted nodules) in which the procedure could be substantially completed by the investigator divided by the number of cases (nodules) for which at least one attempt to pass any LungPoint study device into the bronchoscope was made.

    At completion of procedure

Secondary Outcomes (2)

  • Proportion of nodules biopsied yielding tissue sufficient for diagnosis

    Upon asssessment of histology of tissue sample taken during procedure

  • Number of significant adverse events

    Up through lobectomy of lobe at end of procedure

Interventions

LungPoint ATV SystemDEVICE

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

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical candidates age 21-75 years at screening
  • Known or suspected lung cancer or intrapulmonary metastatic disease with SPN greater than 10 mm and less than 40mm in 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik

Heidelberg, 69126, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25746631DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory 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 25, 2014

First Posted

May 5, 2014

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

DE(1)