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CompletedNCT02130115LABELUpdated May 5, 2014

LungPoint ATV for Biopsy in Patients Undergoing Lobectomy

An interventional study of LungPoint ATV System in Lung Cancer, sponsored by Broncus Medical Inc. Completed at 1 site in Germany. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-05-05.

Sponsored by Broncus Medical Inc · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Lung Cancer
03

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • DeviceLungPoint ATV System

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

05

What researchers measure

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.

    Time frame: At completion of procedure

Secondary outcomes

  1. Proportion of nodules biopsied 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 using the LungPoint ATV system.

    Time frame: Upon asssessment of histology of tissue sample taken during procedure

  2. Number of significant adverse events

    The number of 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. The adverse events specifically tracked in this study are hemoptysis and pneumothorax.

    Time frame: Up through lobectomy of lobe at end of procedure

06

Study locations

1 site
  • Thoraxklinik
    Heidelberg, 69126, Germany
07

References and documents

Publications

  • 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. PubMed 25746631 ↗
08

Registry details

Key details

Study ID
NCT02130115
Lead sponsor
Broncus Medical Inc
Responsible party
Sponsor
First posted
May 5, 2014
Start date
Mar 2013
Primary completion
Sep 2013
Completion
Dec 2013
Last update
May 5, 2014

Study contacts

Felix Herth, MD
principal investigator · Heidelberg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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