NCT02703818

Brief Summary

This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

March 2, 2016

Last Update Submit

November 29, 2018

Conditions

Upper Extremity Pain

Outcome Measures

Primary Outcomes (1)

  • Responder Rate

    3 months

Study Arms (1)

Senza

EXPERIMENTAL

Spinal Cord Stimulation for UEP

Device: Senza

Interventions

SenzaDEVICE

Spinal Cord Stimulation

Senza

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
  • Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
  • Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
  • Be 18 years of age or older at the time of enrollment.
  • Be an appropriate candidate for the surgical procedures required in this study.
  • Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
  • Have stable neurological status measured by motor, sensory and reflex function.

You may not qualify if:

  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
  • Have a current diagnosis of a progressive neurological disease.
  • Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
  • Have mechanical spine instability as determined.
  • Have significant stenosis, based on MRI.
  • Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
  • Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
  • Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
  • Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
  • Be involved in an injury claim under current litigation.
  • Have a pending or approved worker's compensation claim.
  • Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NEVRO Corp

Redwood City, California, 94065, United States

Location

Related Publications (1)

  • Burgher A, Kosek P, Surrett S, Rosen SM, Bromberg T, Gulve A, Kansal A, Wu P, McRoberts WP, Udeshi A, Esposito M, Gliner BE, Maneshi M, Rotte A, Subbaroyan J. Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study. J Pain Res. 2020 Nov 10;13:2837-2851. doi: 10.2147/JPR.S278661. eCollection 2020.

    PMID: 33204145DERIVED

Study Officials

  • David Caraway, MD

    Nevro Corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

May 1, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

US(1)