Thermal Imaging to Diagnose and Monitor Suspected Bacteri... | NCT02292498

Studies
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections

NCT02292498

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

May 3, 2017Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Infections, Bacterial
Pneumonia, Bacterial

Interventions

FLIR ONE

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Nov 14, 2014

First Posted Date

Nov 17, 2014Estimated

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

Apr 28, 2017

Last Update Posted Date

May 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia L. Hibberd, Chief, Division of Pediatric Global Health, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

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 purpose of this study is to test the feasibility of using thermal images to diagnose bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in heat emitted from the chest changes over time if it is possible to obtain serial images of the chest.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLIR ONE thermal camera	Experimental	Thermal camera (FLIR ONE)	Device: FLIR ONE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLIR ONE	Device		FLIR ONE thermal camera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
feasibility of diagnosis of bacterial pneumonia	Thermal imaging will be compared to the chest x-ray taken within 4 hours to see if bacterial pneumonia is present	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject sent for a clinical chest X-ray (not research) to rule out pneumonia
Thermal images obtained using FLIR ONE within 4 hours of the chest x-ray
Signed informed consent obtained
Subject is a patient at a participating clinic at Massachusetts General Hospital

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia L Hibberd, MD, PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections
D018410	Pneumonia, Bacterial
D004194	Disease

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided