Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

NCT ID: NCT03277378

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2018-10-12

Brief Summary

Prospective, multi-center, randomized, single blind study

Detailed Description

This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:

Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.

Conditions

Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (AB)

Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

Group Type: ACTIVE_COMPARATOR

lead placement followed by BurstDR stimulation

Intervention Type: DEVICE

lead placement followed by BurstDR stimulation

Group 2 (TB)

Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

Group Type: ACTIVE_COMPARATOR

lead placement followed by BurstDR stimulation

Intervention Type: DEVICE

lead placement followed by BurstDR stimulation

Interventions

lead placement followed by BurstDR stimulation

lead placement followed by BurstDR stimulation

Intervention Type: DEVICE

Other Intervention Names

Spinal Cord Stimulation non-surgical Leads; Spinal Cord Stimulation Clinician Programmer; Spinal Cord Stimulation Patient Controller

Eligibility Criteria

Inclusion Criteria

1. Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.

2. Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.

3. Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.

4. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.

5. Patient is >18 years of age at the time of enrollment.

6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.

7. Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

Exclusion Criteria

1. Patient currently has a spinal cord stimulation system implanted.

2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).

3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.

4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)

5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robyn Capobianco, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Jason Edward Pope, MD

Santa Rosa, California, United States

Comprehensive Spine Institute

Clearwater, Florida, United States

Florida Pain Institute

Merritt Island, Florida, United States

National Pain Institute Winter Park

Winter Park, Florida, United States

Rush University

Chicago, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Advanced Pain Care

Las Vegas, Nevada, United States

Nevada Advanced Pain Specialists

Reno, Nevada, United States

Oregon Health & Science University

Portland, Oregon, United States

Spinal Diagnostics

Tualatin, Oregon, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Precision Spine Care

Tyler, Texas, United States

St. Mary's Hospital

Huntington, West Virginia, United States

Frankston Pain Management

Frankston, , Australia

North Shore Private Hospital

Saint Leonards, , Australia

Hospital Elisabethinen GmbH

Graz, , Austria

Wilhelminenspital Wien

Vienna, , Austria

Sana Kliniken Duisburg Gm.bH

Duisburg, , Germany

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, , Germany

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

Gera, , Germany

Klinikum Nürnberg Sud

Nuremberg, , Germany

Fondazione Salvatore Maugeri

Pavia, , Italy

Alrijne Ziekenhuis

Leiderdorp, , Netherlands

Stichting Rijnstate Ziekenhuis - Velp

Velp, , Netherlands

University Hospital

Uppsala, , Sweden

Countries

United States; Australia; Austria; Germany; Italy; Netherlands; Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10116

Identifier Type: -

Identifier Source: org_study_id