Suspended

SubQStimSubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PrimeAdvanced® neurostimulator system

+ PrimeAdvanced® neurostimulator system

Device
Who is being recruted

Back Pain+5

+ Neurologic Manifestations

+ Pain

Over 22 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorMedtronicNeuro
Last updated: September 21, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

NCT01818297
Principal SponsorMedtronicNeuro
Last updated: September 21, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

137 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsFailed Back Surgery Syndrome

Criteria

7 exclusion criteria prevent from participating
Currently enrolled in or plan to enroll in another drug and/or device study
Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
Have an active systemic infection or are immunocompromised
Have leg pain in addition to back pain
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant

Group II

Control settings of Medtronic PrimeAdvanced® neurostimulator system implant

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Valley Pain Consultants

Phoenix, United StatesOpen Valley Pain Consultants in Google Maps

HOPE Research Institute

Phoenix, United States

Coastal Pain Research

Carlsbad, United States

Pain Medicine Associates

Fountain Valley, United States
Suspended27 Study Centers