PDN Post Market, Multicenter, Prospective, Global Clinical Study
NCT ID: NCT05301816
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
497 participants
INTERVENTIONAL
2022-07-05
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPG Activated
The group of participants who have had a successful trial (\>50% pain relief) during the trial phase
Spinal Cord Stimulator (SCS)
Spinal cord stimulation system (SCS) is an approved system to manage chronic intractable pain of the limbs and/or leg by delivering electrical stimulation using implantable leads and rechargeable implantable pulse generator (IPG) with 16 output channels. The IPG is implanted in a subcutaneous pocket and is capable of stimulating the spinal cord nerves when used with one or two 8-contact percutaneous or paddle leads.
Interventions
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Spinal Cord Stimulator (SCS)
Spinal cord stimulation system (SCS) is an approved system to manage chronic intractable pain of the limbs and/or leg by delivering electrical stimulation using implantable leads and rechargeable implantable pulse generator (IPG) with 16 output channels. The IPG is implanted in a subcutaneous pocket and is capable of stimulating the spinal cord nerves when used with one or two 8-contact percutaneous or paddle leads.
Eligibility Criteria
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Inclusion Criteria
2. Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at enrollment/baseline.
3. The clinical decision has been made to provide treatment using the Nevro Spinal Cord Stimulation that includes 10 kHz therapy prior to enrollment in the study.
4. Be willing and capable of giving written informed consent.
5. Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits.
Exclusion Criteria
2. Have a medical condition or diagnosis that is inconsistent with Nevro's SCS System guidelines in the Physician's Manual for the relevant country, or as per standard clinical practice.
3. Have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).
18 Years
ALL
No
Sponsors
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Nevro Corp
INDUSTRY
Responsible Party
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Principal Investigators
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David Caraway, MD
Role: STUDY_DIRECTOR
Chief Medical Officer, Nevro Corp
Locations
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Neuroversion, Inc.
Anchorage, Alaska, United States
Michigan Pain Specialists
Ann Arbor, Michigan, United States
Henry Ford Health
West Bloomfield, Michigan, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Clinical Investigations, LLC
Edmond, Oklahoma, United States
Columbia Pain Management
Milwaukie, Oregon, United States
WellSpan Interventional Pain Specialists
York, Pennsylvania, United States
Virginia Interventional Pain & Spine Centers
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Cathy Baker
Role: primary
Alberto Uribe, MD
Role: primary
Cherie Flory, RN
Role: primary
Vikas Bansal, MBBS, MPH
Role: primary
Jessica Pickel
Role: primary
Other Identifiers
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CA2021-03 INT PDN-PM
Identifier Type: -
Identifier Source: org_study_id
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