Spinal Cord InjuryHemON-NLNCT05941819
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
A study testing ARC-IM Thoracic System implantation in people with Spinal Cord Injury and Orthostatic Hypotension, run by ONWARD Medical, Inc. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Orthostatic Hypotension
- What is being tested?
- ARC-IM Thoracic System implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Sep 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Sint Maartenskliniek
Ubbergen, 6574NA
Ilse van Nes, Dr, +31 (0)243659412, I.vanNes@maartenskliniek.nl
About this study
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
- Being tested
- ARC-IM Thoracic System implantation
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-IM Thoracic System implantationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts) Receives: Device: ARC-IM Thoracic System implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout study, average of 15.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ONWARD Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilse Van Nes, MD, PhD, Principal investigator, Sint Maartenskliniek, department of rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941819
- Sponsor's protocol ID
- HemON2022_NL
- Acronym
- HemON-NL
- Status last verified
- Oct 2023
- First submitted
- 4 Jul 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05941819
- Acronym / sponsor ID
- HemON-NL / HemON2022_NL
- Conditions
- Spinal Cord Injury, Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ONWARD Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: ARC-IM Thoracic System implantationAll participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-IM Thoracic System implantationImplantation 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 | Device | All participants |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilse Van Nes, MD, PhD principal investigator
Sint Maartenskliniek, department of rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC-IM Thoracic System implantation in people with Spinal Cord Injury and Orthostatic Hypotension, run by ONWARD Medical, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.