Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007213

Trial Description

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Title

LungPoint ATV for Biopsy in Patients Undergoing Lobectomy

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Trial Acronym

LABEL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00007213
  •   2015/05/19
  •   2014/04/25
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02130115  (ClinicalTrials.gov)
  •   Protocol 40  (Broncus Medical Inc)
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Health Condition or Problem studied

  •   Lung Cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Device: LungPoint ATV System
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

- Ability to complete procedure using system; time frame: At completion of procedure; 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.

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Secondary Outcome

- Proportion of nodules biopsied yielding tissue sufficient for diagnosis; time frame: Upon asssessment of histology of tissue sample taken during procedure; 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.
- Number of significant adverse events; time frame: Up through lobectomy of lobe at end of procedure; 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2013/03/31
  •   12
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   75   Years
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Additional 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

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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

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Addresses

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    • Broncus Medical Inc
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    • Heidelberg University
    • Felix Herth, MD 
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    • Heidelberg University
    • Felix Herth, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.