Status:
COMPLETED
Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
Lead Sponsor:
Celéri Health, Inc.
Collaborating Sponsors:
Medtronic
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Brief Summary
The UPGRADE registry will capture long-term, real-world outcomes to understand the effect of Differential Target Multiplexed (DTM®) programming in the Spinal Cord Stimulation (SCS) implanted populatio...
Detailed Description
This clinical investigation is a prospective, observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on Differential Target Multiplexed (DTM®)...
Eligibility Criteria
Inclusion
- Participant must provide written informed consent prior to any clinical study-related procedure.
- Participant is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system.
- Participant has access to an iPhone or Android capable device and/or computer with regular internet access for the purposes of electronically completing web-based participant self-reported questionnaires via SMS text or email.
Exclusion
- Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
- Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
- Participant is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Participant is pregnant or nursing.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04725838
Start Date
January 29 2021
End Date
July 1 2023
Last Update
August 21 2024
Active Locations (34)
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1
Neuroversion
Anchorage, Alaska, United States, 99508
2
Desert Sky Spine & Sports Medicine
Oro Valley, Arizona, United States, 85755
3
Desert Sky Spine & Sports Medicine
Sierra Vista, Arizona, United States, 85635
4
NuVation Pain Group - Buena Park
Buena Park, California, United States, 90621