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ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (HemON-NL)

Primary Purpose

Spinal Cord Injury, Orthostatic Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ARC-IM Thoracic System implantation
Sponsored by
ONWARD Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 In case participants need continuous support from a personal caregiver in daily life, then the presence of their caregiver during the visits to the study site is needed, including independent transport (not dependent on a cab) 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 Presence of indwelling baclofen (e.g. intrathecal baclofen pump) or insulin pump Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding Lack of safe contraception for women of childbearing capacity Intention to become pregnant during the course of the study, Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant Participation in another study with investigational drug within the 30 days preceding and during the present study Enrolment of the investigator, his/her family members, employees, and other dependent persons

Sites / Locations

  • Sint MaartenskliniekRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
July 4, 2023
Last Updated
September 12, 2023
Sponsor
ONWARD Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05941819
Brief Title
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Acronym
HemON-NL
Official Title
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONWARD Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Orthostatic Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts)
Intervention Type
Device
Intervention Name(s)
ARC-IM Thoracic System implantation
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Throughout study, average of 15.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 In case participants need continuous support from a personal caregiver in daily life, then the presence of their caregiver during the visits to the study site is needed, including independent transport (not dependent on a cab) 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 Presence of indwelling baclofen (e.g. intrathecal baclofen pump) or insulin pump Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding Lack of safe contraception for women of childbearing capacity Intention to become pregnant during the course of the study, Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant Participation in another study with investigational drug within the 30 days preceding and during the present study Enrolment of the investigator, his/her family members, employees, and other dependent persons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilse Van Nes, MD, PhD
Organizational Affiliation
Sint Maartenskliniek, department of rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Ubbergen
ZIP/Postal Code
6574NA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilse van Nes, Dr
Phone
+31 (0)243659412
Email
I.vanNes@maartenskliniek.nl

12. IPD Sharing Statement

Learn more about this trial

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

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