Pilot Study to Evaluate the Clinical Utility of Auscultat... | NCT01138592

Studies
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations

NCT01138592

Sponsor

Solventum US LLC

Status

Completed

Last Update Posted

Oct 1, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Auscultation of Heart and Lungs

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

Sep 2024

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

Jun 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jun 4, 2010

First Submission Date that Met QC Criteria

Jun 4, 2010

First Posted Date

Jun 7, 2010Estimated

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

Sep 27, 2024

Last Update Posted Date

Oct 1, 2024Actual

Name	Class
3M	INDUSTRY

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

Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.

Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.

Detailed Description

Not provided

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary Care Patients		Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confirmation of hub (remote) observations with satellite (local) observations	Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects who are at least 18 years of age
Subjects who are scheduled to undergo examination in a telemedicine setting
Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.

Exclusion Criteria:

Subjects who are unwilling to undergo additional examination in a telemedicine setting,
Any subject requiring time-critical medical intervention.
Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.

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

Primary Care Patients Hepatitis C Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Henley, MD, MPH	North Country Health Care, Flagstaff, AZ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Country Health Care		Flagstaff	Arizona	86004	United States