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Promoting Healing of Nerves Through Electrical Stimulation

NCT04662320 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-05

No results posted yet for this study

Summary

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.

Conditions

  • Cubital Tunnel Syndrome
  • Nerve Compression
  • Nerve Injury
  • Ulnar Neuropathies

Interventions

DEVICE

Checkpoint BEST System

Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair. Other Name: Checkpoint BEST System

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Checkpoint Surgical Inc.

    lead INDUSTRY

Principal Investigators

  • Amy M Moore, MD · The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04662320 on ClinicalTrials.gov