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Usability Study for the Beactive Brace Instructions for Use

NCT02474732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-31

No results posted yet for this study

Summary

FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Therefore, a population of subjects will be tested to determine whether they can properly use the BeActive Brace device after reading the user's guide.

Conditions

  • Lower Back Pain

Interventions

DEVICE

Beactive(r) Brace

Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.

Sponsors & Collaborators

  • Benjamin L. England and Associates, LLC

    lead OTHER

Principal Investigators

  • Michael Caswell · Consumer Product Testing Compahy, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-02-28
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02474732 on ClinicalTrials.gov