An interventional study of Beactive(r) Brace in Lower Back Pain, sponsored by Benjamin L. England and Associates, LLC. Completed. Open to participants aged 22 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by Benjamin L. England and Associates, LLC · Not applicable, Interventional, and Other
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.
The primary objective of this clinical trial is to evaluate the ability of approximately 40 literate adults to understand the label instructions for deploying the Beactive(r) Brace device as described in the user's guide, without physician direction. The primary endpoint of this clinical trial is the successful completion of all essential tasks required for Beactive(r) Brace deployment by a subject.
Subjects will be seated at a table facing a video camera, so Investigators and the Sponsor may observe the subject via closed circuit television. Subjects will be given the user's guide for the Beactive(r) Brace device. The subject will then be asked to deploy the Beactive(r) Brace device according to their understanding following the user's guide. For this clinical trial, deploying is defined as completing the following two tasks.
If the tasks can be completed with no intervention, the subject would be judged to have a "comprehensive" level of success. If intervention was required and helpful, and the subject was able to complete all essential tasks, the level of success would be judged "sufficient." The steps where intervention took place will be recorded.
Intervention will be allowed and documented if subjects have difficulty with a specific task. The subject will raise their hand and a technician will be available for assistance. The frequency and type of intervention will be documented.
A Study Coordinator will complete an observer questionnaire for each subject based on their observation of each subject's ability to use the Beactive device correctly. Each subject will complete a user questionnaire, which will confirm their understanding of the user's guide and give them the opportunity to provide feedback and suggestions for improving the user's guide.
2,820 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →This is the only study on the registry with Benjamin L. England and Associates, LLC as lead sponsor.
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Exclusion Criteria:
Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.
Device: Beactive(r) Brace
Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.
Number of Subjects Correctly Following Instructions for Use
Subjects were observed as they read the instructions for use and applied the Beactive(r) Brace.
Time frame: Five minutes
No study locations are listed for this record.
Plan to share: No — Redacted individual participant data is available through the Freedom of Information Act process through the FDA
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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