Rainbow Acoustic Monitoring (RAM) Clinical Engineering Da... | NCT03120897

Studies
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

NCT03120897

Sponsor

Masimo Corporation

Status

Terminated

Last Update Posted

May 18, 2021Actual

Enrollment

78Actual

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

RAM sensor

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 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to terminate study.

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Oct 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 14, 2017

First Posted Date

Apr 19, 2017Actual

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

May 17, 2021

Last Update Posted Date

May 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population

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

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	The subjects will be enrolled into the test group and will receive RAM sensor.	Device: RAM sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RAM sensor	Device	Rainbow Acoustic Monitoring sensor for measurement of respiratory rate	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects in which respiratory rate is collected	Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor	Duration of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female subjects that are between 0 to 70 years old.
Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

Exclusion Criteria:

Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
Patients who the PI deems ineligible at the PI's discretion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided