percutaneous Utah Slanted Electrode Arrays (pUSEAs) for Amputations

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University Orthopaedic Center, Salt Lake City, UT
Amputations
percutaneous Utah Slanted Electrode Arrays (pUSEAs) - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 2-years Follow-up

Up to 2-years Follow-up
Measure Action Potentials (millivolts, mV)

Trial Safety

Trial Design

1 Treatment Group

Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)
1 of 1
Experimental Treatment

3 Total Participants · 1 Treatment Group

Primary Treatment: percutaneous Utah Slanted Electrode Arrays (pUSEAs) · No Placebo Group · N/A

Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)
Device
Experimental Group · 1 Intervention: percutaneous Utah Slanted Electrode Arrays (pUSEAs) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2-years follow-up
Closest Location: The University Orthopaedic Center · Salt Lake City, UT
Photo of Salt Lake City 1Photo of Salt Lake City 2Photo of Salt Lake City 3
2021First Recorded Clinical Trial
2 TrialsResearching Amputations
1 CompletedClinical Trials

Who is running the clinical trial?

University of UtahLead Sponsor
976 Previous Clinical Trials
1,759,506 Total Patients Enrolled
3 Trials studying Amputations
51 Patients Enrolled for Amputations
Douglas Hutchinson, M.D.Principal InvestigatorUniversity of Utah Orthopaedics

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged between 18 and 65 years.\n
You have a unilateral or bilateral traumatic or elective upper extremity amputation at the transradial level.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.