Last updated: October 31, 2023
Sponsor: ONWARD Medical, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Orthostatic Hypotension
Dizzy/fainting Spells
Vascular Diseases
Treatment
ARC-IM Thoracic System implantation
Clinical Study ID
NCT05941819
HemON2022_NL
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theinvestigators
- 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 allscheduled 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
Exclusion Criteria:
- Diseases and conditions that would increase the morbidity and mortality of spinal cordinjury surgery
- Diseases and conditions that would require regular MRI
- The inability to perform an MRI due to metal, magnetic or electrical device in thebody (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heartvalve, 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 thejudgement 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 theenrolment
- 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, hepaticdysfunction, 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 precedingand during the present study
- Enrolment of the investigator, his/her family members, employees, and other dependentpersons
Study Design
Total Participants: 16
Treatment Group(s): 1
Primary Treatment: ARC-IM Thoracic System implantation
Phase:
Study Start date:
September 05, 2023
Estimated Completion Date:
September 30, 2025
Connect with a study center
Sint Maartenskliniek
Ubbergen, 6574NA
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.