A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

NCT02738840 | Completed Results

• 1 other identifier: CRD_800
• Study Type: interventional
• Target: 56
• Locations: 7 countries
• Sites: 10

Brief Summary

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• The Rate of the MRI Scan-related Adverse Events

  The rate of the MRI scan-related adverse events will be assessed at 1-month follow-up.

  1 month post MRI scan

Secondary Outcomes (11)

• Rate of Successful MRI Mode 'Turn on' Functionality

  Immediately before MRI Scan

• Rate of Successful MRI Mode 'Turn Off' Functionality

  Immediately after MRI Scan

• Rate of Successful 'Turn Off' Functionality for the Stimulation

  Immediately before MRI Scan

• Rate of Successful 'Turn on' Functionality for the Stimulation

  Immediately after MRI Scan

• Rate of Successful 'Turn on/Off' Functionality for the Stimulation

  At 1 month follow-up

Study Arms (1)

Prodigy MRI or Proclaim Elite MR

EXPERIMENTAL

The Prodigy MRI system is only MR conditional for scans of the head and extremities (upper except shoulder, lower except hip). The Proclaim Elite system is MR conditional for scans of the head, extremities or any other body part.

Procedure: MRI scan

Interventions

MRI scan PROCEDURE

MRI scan

Prodigy MRI or Proclaim Elite MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
• Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
• Patient is ≥ 18 years of age
• Patient must be willing and able to comply with study requirements
• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

You may not qualify if:

• Patient has another implanted device (active or passive) that prohibits safe scanning
• Patient has previously experienced an MRI scan-related adverse event
• Patient is currently enrolled in another Abbott study that collects MRI safety data
• Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (10)

Napa Valley Orthopedic Medical Group

Napa, California, 94558, United States

Location

Unity Spine Center

Rochester, New York, 14626, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Wilhelminenspital Wien

Vienna, 1160, Austria

Location

AZ Sint-Augustinus

Wilrijk, Belgium

Location

Medizinische Einrichtungen der Universität Düsseldorf, Dusseldorf

Düsseldorf, Germany

Location

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie, Gera

Gera, Germany

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Hospital Virgen de Rocio

Seville, Spain

Location

Seacroft Hospital

Leeds, Ykshre, LS14 6UH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Robyn A Capobianco
• Organization: Abbott

robyn.capobianco@abbott.com

+1 512 934 3941

Study Officials

• Nicole Harbert

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: International, multicenter, prospective, and single-arm design

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: October 21, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 2, 2020
• Last Updated: June 10, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (3); DE (2); IT (1); ES (1); GB (1); AU (1)