Vibration Response Imaging (VRI) in Patients That Are Can... | NCT00523094

Studies
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

NCT00523094

Sponsor

Deep Breeze

Status

Suspended

Last Update Posted

Jun 16, 2009Estimated

Enrollment

75Estimated

Phase

Not provided

Conditions

Emphysema
Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment was too slow and principal investigator moved to another country

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Jul 2008Estimated

First Submitted Date

Aug 29, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2009

Last Update Posted Date

Jun 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan.

The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who underwent surgical resection.

Detailed Description

Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office.

Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.

In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to read, understand, and provide written informed consent;
Male or female in the age range of 18-80 years;
Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
Body mass index (BMI) > 21.

Exclusion Criteria:

Chest wall deformation;
Spine deformation (including scoliosis);
Hirsutism;
Potentially contagious skin lesion on the back;
Skin lesion that would interfere with sensor placement; (Keloids)
Cardiac pacemaker or implantable defibrillator;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients evaluated for lung surgery who will undergo perfusion scan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Atul C. Mehta, M.D	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14733622	Background	Benditt JO. Surgical therapies for chronic obstructive pulmonary disease. Respir Care. 2004 Jan;49(1):53-61; discussion 61-3.
9465866	Background	Gurney JW. Pathophysiology of obstructive airways disease. Radiol Clin North Am. 1998 Jan;36(1):15-27. doi: 10.1016/s0033-8389(05)70005-1.

ID	Term
D004646	Emphysema
D009369	Neoplasms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms