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ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

NCT05941819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-01

No results posted yet for this study

Summary

The goal of this interventional study is to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury.

Participants will be implanted with the ARC-IM Thoracic System which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.

Conditions

  • Spinal Cord Injury
  • Orthostatic Hypotension

Interventions

DEVICE

ARC-IM Thoracic System implantation

Implantation of the ARC-IM Thoracic Lead on the low thoracic level of the spinal cord and implantation of the ARC-IM IPG in the abdominal region

Sponsors & Collaborators

  • ONWARD Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ilse Van Nes, MD, PhD · Sint Maartenskliniek, department of rehabilitation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Netherlands

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 NCT05941819 on ClinicalTrials.gov