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Electrode Array

HAPTIX System for Amputees

N/A
Recruiting
Led By Douglas Hutchinson, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2-years follow-up
Awards & highlights

Study Summary

This trial will test if a new device, the HAPTIX system, can provide a sense of touch and muscle feedback to people with limb amputations.

Who is the study for?
This trial is for adults under 65 with one or both arms amputated at the forearm level. Candidates must be able to give consent and not have health issues that make anesthesia very risky. Pregnant individuals, prisoners, or those with certain psychiatric conditions cannot participate.Check my eligibility
What is being tested?
The study tests if tiny electrodes implanted in nerves of the arm stump can record signals and help control a prosthetic limb while providing touch feedback. The device called pUSEAs will be used alongside muscle sensors as part of the HAPTIX System.See study design
What are the potential side effects?
Potential side effects may include discomfort at implant sites, infection risk from surgery, possible nerve damage leading to altered sensation or pain, and general risks associated with receiving anesthesia during the procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2-years follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2-years follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure Action Potentials (millivolts, mV)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)Experimental Treatment1 Intervention
The arm (s) of the patient which has been amputated. Intervention include insertion of the percutaneous Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,686 Total Patients Enrolled
Douglas Hutchinson, M.D.Principal InvestigatorUniversity of Utah Orthopaedics

Media Library

percutaneous Utah Slanted Electrode Arrays (pUSEAs) (Electrode Array) Clinical Trial Eligibility Overview. Trial Name: NCT05505513 — N/A
Amputation Research Study Groups: Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)
Amputation Clinical Trial 2023: percutaneous Utah Slanted Electrode Arrays (pUSEAs) Highlights & Side Effects. Trial Name: NCT05505513 — N/A
percutaneous Utah Slanted Electrode Arrays (pUSEAs) (Electrode Array) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505513 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open call for participants in this research effort?

"The details of the trial, which were initially published on December 21st 2020 and last adjusted on August 15th 2022, indicate that no further recruitment is underway. Despite this, 66 other medical trials are actively searching for candidates at present."

Answered by AI

What qualifications must one fulfill in order to participate in this trial?

"This trial seeks 3 subjects aged 18 to 65 who have experienced either a traumatic or elective amputation of one or both upper extremities at the transradial level."

Answered by AI

Does the study permit seniors to participate?

"This research project is only enrolling individuals who are over the age of consent and younger than 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
Douglas Hutchinson 2020. "Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05505513.
~1 spots leftby Dec 2025
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