Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs (Prodigy-I)

January 22, 2024 updated by: Abbott Medical Devices

A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.

The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Caulfield, Australia, 3162
        • Metro Spinal Clinic
      • Frankston, Australia
        • Frankston Pain Management
      • Richmond, Australia
        • Epworth Hospital
  • Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • St Augustinus Ziekenhuis
  • Germany
      • Duesseldorf, Germany
        • University Hospital
      • Gera, Germany, 07548
        • Hospital Gera
      • Köln, Germany
        • Medizinische Einrichtungen der Universität zu Koln
      • Magdeburg, Germany
        • Universitätsklinik für Stereataktische Neurochirurgie
      • Tubingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Ireland
      • Dublin, Ireland
        • St Vincents University Hospital
  • Italy
      • Napoli, Italy
        • Azienda Ospedaliera Monaldi
      • Pisa, Italy, 56126
        • Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
      • Roma, Italy, 00184
        • Az. Osp.S.Giovanni Addolorata
  • Netherlands
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Nieuwegein, Netherlands
        • St Antonius Ziekenhuis
      • Velp, Netherlands
        • Stichting Alysis Zorggroep
  • Spain
      • Sevilla, Spain, 28108
        • Hospital Virgen de Rocio
  • Sweden
      • Uppsala, Sweden, 75 185
        • University Hospital
  • United Kingdom
      • Leeds, United Kingdom, LS146UH
        • Seacroft Hospital
      • London, United Kingdom, EC 1A 7 BE
        • St Bartolomew's
      • Middlesbrough, United Kingdom
        • James Cook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients who are indicated for Spinal Cord Stimulation (SCS) and with Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.

Description

Inclusion Criteria:

  • Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
  • Patient diagnosed with radiculopathy
  • Patient diagnosed with neuropathic pain
  • Patient is considered by the investigator as a candidate for implantation of a 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

Exclusion Criteria:

  • Patient is diagnosed with ischemic pain
  • Patient is diagnosed with arachnoiditis
  • Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
  • Patient is diagnosed with peripheral vascular disease (PVD)
  • Patient is diagnosed with diabetic neuropathic pain
  • Patient is diagnosed with chronic migraine
  • Patient is immune-compromised
  • Patient has history of cancer requiring active treatment in the last 6 months
  • Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
  • Patients with a SCS system or implantable infusion pump implanted previously
  • Patient has a life expectancy of less than one year
  • Patient is pregnant or is planning to become pregnant during the duration of the investigation
  • Patient is unable to comply with the follow up schedule
  • Patient needing legally authorized representative
  • Patient unable to read and write
  • Patient is currently participating in another clinical investigation with an active treatment arm.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Burst and Tonic stimulation
All subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion.
Procedure: Burst and Tonic stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Overall VAS at 3 Months
Time Frame: 3 months
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "[(post baseline baseline)/baseline] *100%" with positive numbers to represent increases and negative numbers to represent decreases.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Relief
Time Frame: 3 Months
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
3 Months
Pain Relief
Time Frame: 6 Months
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
6 Months
Pain Relief
Time Frame: 12 Months
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain and 100% being complete pain relief.
12 Months
Change in Pain Catastrophizing Scale
Time Frame: 12 Months
The pain catastrophizing scale (PCS) is a validated scale containing 13 items to assess thoughts and feelings about pain while a person is experiencing pain. The total of all 13 items results in a minimum of 0 and a maximum of 54; scores above 30 indicate clinically significant pain catastrophizing. The mean change was calculated based on the value at 12 months minus the value at baseline.
12 Months
Number of Participants With Analgesic Reduction
Time Frame: 12 Months
Patient reported analgesic usage during the 4 weeks preceding the 12-month follow-up visit, compared to the baseline visit. The amount of patients who decreased the dose are reported.
12 Months
Change in Quality of Life
Time Frame: Baseline and 12 Months
Subjects were provided with the Euroqol-5 dimensions (EQ-5D) questionnaire at baseline and 12 Months follow-up visit. In that questionnaire, subjects were asked to indicate a score for their health on a scale where 100 would mean 'the best state he/she can imagine' and 0 would be the 'worst state he/she can imagine).
Baseline and 12 Months
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Time Frame: from enrollment to 12 months follow up
Adverse device effects were defined as adverse events related to the study procedures or the device. Serious events were those that resulted in-patient or prolonged hospitalization or were life-threatening.
from enrollment to 12 months follow up
Paresthesia Mapping at 3 Months Compared to the Empower Study
Time Frame: 3 Months
Paresthesia mapping is expressed in percent of paresthesia areas as indicated by the patient on a gender specific body diagram. 87 subjects with Burst stimulation at 3 Months (Prodigy-I) were compared to 134 subjects with tonic stimulation at 3 Months (Empower).
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tony Van Havenbergh, St Augustinus, Wilrijk, Belgium
  • Study Director: Devyani Nanduri, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NM-13-038-ID-SC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings