PDN Post Market, Multicenter, Prospective, Global Clinical Study

Conditions

• Diabetic Neuropathy, Painful

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Spinal Cord Stimulator (SCS) — DEVICE
  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.

Study Details

The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.

Key Dates

Start date

Jul 5, 2022

Status verified

Nov 2024

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

497 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: IPG Activated
  The group of participants who have had a successful trial (\>50% pain relief) during the trial phase

Primary Outcome Measure

Trial success rate/Responder rate [ Time Frame: 2 weeks ]

Central Contacts

• Kerry Bradley
  1-650-251-0005
  [email protected]
• Manish Bharara, PhD
  1 (650) 785 1061
  [email protected]

Locations (8)

Find similar trials in Anchorage, AK