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

ONWARD Medical, Inc.1 site in 1 country16 target enrollmentSeptember 5, 2023

ConditionsSpinal Cord Injury Orthostatic Hypotension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: ONWARD Medical, Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: Occurence of Serious Adverse Event and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Thoracic System
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 5, 2023

End Date

September 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ONWARD Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or older
•Must provide and sign the Informed Consent prior to any study-related procedures
•Traumatic Spinal Cord Injury
•Spinal cord injury lesion level between C3 and T6 (inclusive)
•AIS- A, B, C or D
•SCI ≥ 1month
•Confirmed orthostatic hypotension
•Stable medical, physical and psychological condition as considered by the investigators
•Able to understand and interact with the study team in Dutch or English
•Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Exclusion Criteria

•Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
•Diseases and conditions that would require regular MRI
•The inability to perform an MRI due to metal, magnetic or electrical device in the body (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heart valve, clips, stents...) as assessed by the MRI form of Sint Maartenskliniek
•The inability to withhold antiplatelet/anticoagulation agents perioperatively
•History of myocardial infarction or cerebrovascular event within the past 6 months
•Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
•Clinically significant mental illness in the judgement of the investigators
•Botulinum toxin non-vesical and vesical injections in the previous 3 months before the enrolment
•Presence of significant pressure ulcers
•Recurrent urinary tract infection refractory to antibiotics

Outcomes

Primary Outcomes

Occurence of Serious Adverse Event and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Thoracic System

Time Frame: Throughout study, average of 15.5 months

Assess the safety of ARC-IM Therapy at supporting the management of hemodynamic instability with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension