Status:
COMPLETED
Motor, Sensory, and Autonomic Function in Traumatic Spinal Cord Injury After the LION Procedure.
Lead Sponsor:
Spinal Cord Injury Centre of Western Denmark
Collaborating Sponsors:
Aarhus University Hospital
Regionshospitalet Viborg, Skive
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Possover pioneered a minimally invasive and fully reversible laparoscopic technique, laparoscopic implantation of neuroprosthesis (LION), for precise placement of an implantable pulse generator and on...
Detailed Description
Sustaining a spinal cord injury impacts the mental and physical wellbeing of the injured individuals profoundly; quality of life suffers and subsequently the risk of suicide is greatly increased as co...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent for participation in the clinical investigation, and to comply with all requirements of the clinical investigation
- Traumatic SCI with:
- neurological level below T5 and above L2
- American Spinal Injury Association Impairment Grade A or B
- spasticity in one or both lower extremities
- Injury prior at least 12 months prior to enrollment
Exclusion
- Female subject who is pregnant/planning pregnancy during the clinical investigation.
- Previous surgery/procedures interfering with the LION procedure incl. the presence of other implanted medical devices.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the clinical investigation, or may influence the result of the clinical investigation, or the subject's ability to participate in the clinical investigation
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03441256
Start Date
January 1 2018
End Date
December 31 2020
Last Update
September 28 2021
Active Locations (1)
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1
Helge Kasch
Viborg, Central Jutland, Denmark, 8800