NCT02385201

Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck Pain

Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nevro Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center feasibility study of effectiveness and safety of the Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.

Detailed description

Study subjects will be identified from the pool of candidates for SCS therapy affiliated with, or referred to, the clinical sites. Subjects will participate in this investigational plan that includes entry criteria evaluation, Baseline assessments, trial stimulation phase, and post-trial assessment. Subjects with a successful Trial Phase will receive a permanent implant of an Implantable Pulse Generator (IPG) and leads, and undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation. Subjects who sign the informed consent will undergo evaluations to determine eligibility for the study based on the inclusion and exclusion criteria. Baseline assessments will also include measures for pain, disability, functioning, medication use, quality of life, depression and sleep. Implantation and use of the Senza System will follow the Nevro Physician's Manual and supporting Manuals. Subjects will undergo a Trial Phase lasting up to 14 days to determine his/her response to SCS therapy. Following the Trial Phase with external device stimulation, subjects will be assessed for their pain, and those who have a successful Trial Phase will be eligible to proceed to permanent implantation of a SCS system. Following permanent device implant, the IPG will be "activated" and thus, stimulation delivered on an ongoing basis for 12 months. At 1 month and 9 months following Post-Permanent Device Activation, assessments of pain and adverse events will be made. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse events as well as disability, functioning, medication use, quality of life, depression and sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.

Conditions

• Neck Pain
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Senza	Spinal Cord Stimulation

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2018-03-01
• First posted: 2015-03-11
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States