Pulmonary Coin LesionPhase 4ALOSPNDYNCT01389154
Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices
A Phase 4 study testing Lung biopsy using Always On EM Tip Tracked Device in people with Pulmonary Coin Lesion, run by Veran Medical Technologies.
Trial summary
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Coin Lesion
- What is being tested?
- Lung biopsy using Always On EM Tip Tracked Device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provides informed consent
- Subject is older than 50 years of age with 50% of patients at least 65 years of age
- Patient has a minimum of 20 pack years
- Subject scheduled to undergo conventional bronchoscopy as part of their standard medical care
- Subject has radiographically confirmed sub-segmental peripheral < 3.0 cm lung lesions
- A negative pregnancy test in women of child-bearing potential
- Subject is willing and able to return for all required follow-up
- Subject is mentally capable of following study directions
Who cannot join
- Subject has pacemaker, implantable cardioverter, and/or defibrillator
- Subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy prior to their enrollment in this study
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
About this study
Official title: A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional bronchoscopy.
Read the detailed description
Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical Technologies system are Food and Durg Administration 510K approved for use in diagnostic pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter lung lesions or solitary pulmonary nodules(SPN).
Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to participate in the study and proceed with informed consent. An interim analysis of the data will be conducted to determine the need to include an additional 10 patients to achieve statistically significant results at the ninety five percent confidence interval.
- Conditions
- Pulmonary Coin Lesion
- Being tested
- Lung biopsy using Always On EM Tip Tracked Device
- Keywords
- diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung biopsy using Always On EM Tip Tracked DeviceProcedure or surgery
Also called Always On Electromagnetic Tip Tracked Diagnostic Yield
Patients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients recommended for a lung biopsy. | Experimental | Patients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study. Receives: Procedure: Lung biopsy using Always On EM Tip Tracked Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures.
Measured: Within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: Product Enhancements completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Coin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veran Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Quality Resource Management
- Responsible party
- Sponsor
- Investigators
- Momen Wahidi, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389154
- Sponsor's protocol ID
- VMT-SPiN_01
- Acronym
- ALOSPNDY
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2011
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.
PubMed 12527571Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.
PubMed 10492275Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD; American College of Chest Physicians. The solitary pulmonary nodule. Chest. 2003 Jan;123(1 Suppl):89S-96S. doi: 10.1378/chest.123.1_suppl.89s.
PubMed 12527568Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.
PubMed 12527563Edell E, Krier-Morrow D. Navigational bronchoscopy: overview of technology and practical considerations--new Current Procedural Terminology codes effective 2010. Chest. 2010 Feb;137(2):450-4. doi: 10.1378/chest.09-2003. Epub 2009 Dec 4.
PubMed 19965952Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. doi: 10.1378/chest.129.1.147.
PubMed 16424425Shirakawa T, Imamura F, Hamamoto J, Honda I, Fukushima K, Sugimoto M, Shirkakusa T. Usefulness of endobronchial ultrasonography for transbronchial lung biopsies of peripheral lung lesions. Respiration. 2004 May-Jun;71(3):260-8. doi: 10.1159/000077424.
PubMed 15133346Landi S, Cenni MC, Maffei L, Berardi N. Environmental enrichment effects on development of retinal ganglion cell dendritic stratification require retinal BDNF. PLoS One. 2007 Apr 4;2(4):e346. doi: 10.1371/journal.pone.0000346.
PubMed 17406670Makris D, Scherpereel A, Leroy S, Bouchindhomme B, Faivre JB, Remy J, Ramon P, Marquette CH. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007 Jun;29(6):1187-92. doi: 10.1183/09031936.00165306. Epub 2007 Mar 14.
PubMed 17360724Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22.
PubMed 17379850Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.
PubMed 16873767Lamprecht B, Porsch P, Pirich C, Studnicka M. Electromagnetic navigation bronchoscopy in combination with PET-CT and rapid on-site cytopathologic examination for diagnosis of peripheral lung lesions. Lung. 2009 Jan-Feb;187(1):55-9. doi: 10.1007/s00408-008-9120-8. Epub 2008 Oct 5.
PubMed 18836886Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.
PubMed 16608948Hautmann H, Schneider A, Pinkau T, Peltz F, Feussner H. Electromagnetic catheter navigation during bronchoscopy: validation of a novel method by conventional fluoroscopy. Chest. 2005 Jul;128(1):382-7. doi: 10.1378/chest.128.1.382.
PubMed 16002960
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
- ClinicalTrials.gov ID
- NCT01389154
- Acronym / sponsor ID
- ALOSPNDY / VMT-SPiN_01
- Conditions
- Pulmonary Coin Lesion
- Keywords
- diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Product Enhancements completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Veran Medical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Quality Resource Management
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional bronchoscopy.
Detailed description
Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical Technologies system are Food and Durg Administration 510K approved for use in diagnostic pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter lung lesions or solitary pulmonary nodules(SPN).
Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to participate in the study and proceed with informed consent. An interim analysis of the data will be conducted to determine the need to include an additional 10 patients to achieve statistically significant results at the ninety five percent confidence interval.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients recommended for a lung biopsy. | Experimental | Procedure: Lung biopsy using Always On EM Tip Tracked DevicePatients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject provides informed consent
- Subject is older than 50 years of age with 50% of patients at least 65 years of age
- Patient has a minimum of 20 pack years
- Subject scheduled to undergo conventional bronchoscopy as part of their standard medical care
- Subject has radiographically confirmed sub-segmental peripheral < 3.0 cm lung lesions
Key exclusion criteria (5 listed)
- Subject has pacemaker, implantable cardioverter, and/or defibrillator
- Subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy prior to their enrollment in this study
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung biopsy using Always On EM Tip Tracked DeviceAlso: Always On Electromagnetic Tip Tracked Diagnostic YieldPatients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment. | Procedure or surgery | Patients recommended for a lung biopsy. |
Primary outcome
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
Time frame: Within 1 week
Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Background: PubMed 12527571Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.
- Background: PubMed 10492275Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.
- Background: PubMed 12527568Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD; American College of Chest Physicians. The solitary pulmonary nodule. Chest. 2003 Jan;123(1 Suppl):89S-96S. doi: 10.1378/chest.123.1_suppl.89s.
- Background: PubMed 12527563Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.
- Background: PubMed 19965952Edell E, Krier-Morrow D. Navigational bronchoscopy: overview of technology and practical considerations--new Current Procedural Terminology codes effective 2010. Chest. 2010 Feb;137(2):450-4. doi: 10.1378/chest.09-2003. Epub 2009 Dec 4.
- Background: PubMed 16424425Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. doi: 10.1378/chest.129.1.147.
- Background: PubMed 15133346Shirakawa T, Imamura F, Hamamoto J, Honda I, Fukushima K, Sugimoto M, Shirkakusa T. Usefulness of endobronchial ultrasonography for transbronchial lung biopsies of peripheral lung lesions. Respiration. 2004 May-Jun;71(3):260-8. doi: 10.1159/000077424.
- Background: PubMed 17406670Landi S, Cenni MC, Maffei L, Berardi N. Environmental enrichment effects on development of retinal ganglion cell dendritic stratification require retinal BDNF. PLoS One. 2007 Apr 4;2(4):e346. doi: 10.1371/journal.pone.0000346.
- Background: PubMed 17360724Makris D, Scherpereel A, Leroy S, Bouchindhomme B, Faivre JB, Remy J, Ramon P, Marquette CH. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007 Jun;29(6):1187-92. doi: 10.1183/09031936.00165306. Epub 2007 Mar 14.
- Background: PubMed 17379850Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22.
- Background: PubMed 16873767Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.
- Background: PubMed 18836886Lamprecht B, Porsch P, Pirich C, Studnicka M. Electromagnetic navigation bronchoscopy in combination with PET-CT and rapid on-site cytopathologic examination for diagnosis of peripheral lung lesions. Lung. 2009 Jan-Feb;187(1):55-9. doi: 10.1007/s00408-008-9120-8. Epub 2008 Oct 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momen Wahidi, MD, MBA principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lung biopsy using Always On EM Tip Tracked Device in people with Pulmonary Coin Lesion, run by Veran Medical Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm. (time frame: Within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389154, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.