Accuracy & Usability Study for Soberlink Cellular Device

Status Completed

Clinical Trial Summary

This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.

Clinical Trial Description

The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.

The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02794038
Study type	Interventional
Source	Soberlink Healthcare LLC
Contact
Status	Completed
Phase	N/A
Start date	June 2016
Completion date	June 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04070521` - EEG Monitoring in the Emergency Department
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Active, not recruiting	`NCT03129334` - Preventing Prescription Drug Abuse in Middle School Students	N/A
Completed	`NCT02733003` - Implementation Research for Vulnerable Women in South Africa	N/A
Completed	`NCT02573948` - Feasibility of Interventions on People Who Inject Drugs in Vietnam
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Withdrawn	`NCT01847300` - cSBI-M for Young Military Personnel	N/A
Withdrawn	`NCT01523444` - Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings	Phase 3
Completed	`NCT01481428` - Reducing High Risk Behavior in Treatment Court	Phase 1
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Active, not recruiting	`NCT00847548` - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting	N/A
Completed	`NCT01614015` - Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial	Phase 2
Withdrawn	`NCT01228890` - Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)	Phase 3
Completed	`NCT01621334` - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use	Phase 1
Completed	`NCT00841711` - Transitions: Linkages From Jail To Community	N/A
Completed	`NCT00717444` - Healthy Activities for Prize Incentives	N/A
Completed	`NCT00685074` - Computer-based Brief Intervention for Perinatal Substance Abuse	Phase 1/Phase 2
Completed	`NCT01465490` - Monitoring and Feedback in Substance Abuse Treatment	Phase 1/Phase 2
Completed	`NCT01188434` - Integrating Interventions for Maternal Substance Abuse	Phase 1