Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Epineuron Technologies Inc.
Study ID
NCT05721261
Status
Recruiting
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Conditions

  • Nerve Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Temporary Peripheral Nerve Stimulation System — DEVICE
    Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
  • Sham Temporary Peripheral Nerve Stimulation System — DEVICE
    Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

Study Details

A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Key Dates

Start date
Aug 11, 2023
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active treatment
  • Sham Comparator: Sham treatment

Primary Outcome Measure

Sensory recovery [ Time Frame: 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Florida HealthGainesvilleFlorida32608
Ellen Satteson, MD (PRINCIPAL_INVESTIGATOR)
Tarek A El-Gammal, MD, PhD (SUB_INVESTIGATOR)
Jongmin Kim, MD (SUB_INVESTIGATOR)
Orlando Health Jewett Orthopedic InstituteOrlandoFlorida32806
Karan Desai, MD, FAAOS (PRINCIPAL_INVESTIGATOR)
Justin Zumsteg, MD, FAAOS (SUB_INVESTIGATOR)
Louisiana State University Health Sciences CenterNew OrleansLouisiana70112
Harvey Chim, MD, FACS (PRINCIPAL_INVESTIGATOR)
Kelly Babineaux, MD, FACS (SUB_INVESTIGATOR)
Omer Kaymakcalan, MD (SUB_INVESTIGATOR)
The Curtis National Hand CenterBaltimoreMaryland21218-
WellSpan HealthYorkPennsylvania17403-
John Peter Smith HospitalFort WorthTexas76104
William Pientka II, MD, FAAOS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida Health· Gainesville, FLOrlando Health Jewett Orthopedic Institute· Orlando, FLLouisiana State University Health Sciences Center· New Orleans, LAThe Curtis National Hand Center· Baltimore, MDWellSpan Health· York, PAJohn Peter Smith Hospital· Fort Worth, TX

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