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Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices (ALOSPNDY)

Primary Purpose

Pulmonary Coin Lesion

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Lung biopsy using Always On EM Tip Tracked Device

About this trial

This is an interventional diagnostic trial for Pulmonary Coin Lesion focused on measuring diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients recommended for a lung biopsy.

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01389154

First Posted

July 1, 2011

Last Updated

July 16, 2014

Sponsor

Veran Medical Technologies

Collaborators

Institute for Quality Resource Management

1. Study Identification

Unique Protocol Identification Number

NCT01389154

Brief Title

Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices

Acronym

ALOSPNDY

Official Title

A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Product Enhancements completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Veran Medical Technologies

Collaborators

Institute for Quality Resource Management

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Coin Lesion

Keywords

diagnostic yield, Electromagnetic Tip Tracked, peripheral lung lesion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients recommended for a lung biopsy.

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Lung biopsy using Always On EM Tip Tracked Device

Other Intervention Name(s)

Always On Electromagnetic Tip Tracked Diagnostic Yield

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.

Description

Time Frame

Within 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Momen Wahidi, MD, MBA

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

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12527571

Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices

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