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Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator (REALITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03876054
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Prospective, post-market, non-randomized, single-arm, open-label study.

Condition or disease Intervention/treatment
Chronic Pain Device: Spinal cord stimulation (SCS) Device: Dorsal root ganglion stimulation (DRG)

Detailed Description:
The REALITY study is a post-market, prospective, non-randomized, single-arm, open-label study. It is intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems. This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : April 2028
Estimated Study Completion Date : April 2029

Group/Cohort Intervention/treatment
Spinal cord stimulation (SCS)
Subjects using Abbott SCS systems
Device: Spinal cord stimulation (SCS)
Subjects will be implanted with market-released Abbott SCS systems

Dorsal root ganglion stimulation (DRG)
Subjects using Abbott DRG system
Device: Dorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system




Primary Outcome Measures :
  1. Evaluation of device related adverse events [ Time Frame: 5 years ]
    Collecting device related adverse events


Other Outcome Measures:
  1. Clinical improvement from baseline to each follow up visit assessed by using PROMIS-29 [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    Patient Reported Outcomes Measurement Information System Adult Profile (PROMIS 29) - assess the overall quality of life

  2. Clinical improvement from baseline to each follow up visit assessed by Numeric Rating Scale (NRS) for pain intensity, [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    Pain reported from 0 "no pain" - 10 "worst imaginable pain"

  3. Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    A measure of "an exaggerated negative mental set brought to bear during actual or anticipated painful experience."

  4. Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI) (optional) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    A scale for measuring back-related physical function. Each section in the scale covers a different domain (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored on a scale from 0-5 with the first item scored a "0" and representing no disability. The final item is scored a "5" and represents the maximum level of disability. The scores for each section are summed for a final score ranging from 0 to 50. For example: Example: 16 points scored on all 10 items (max 50) equals 32%. However, 16 points scored over 9 items (max 45) equals 35.6%. The final scores are categorized as follows: 0% to 20%: minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled, 81%-100%

  5. Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    Information about medication usage

  6. Clinical improvement from baseline to each follow up visit assessed by transcutaneous oxygen pressure measurement (TcPO2) [ Time Frame: Baseline, 6-month, 1-, 2-, 3-, 4-, 5-year ]
    TcPO2 is used to measure oxygen level of the tissue below the skin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Criteria

Inclusion Criteria:

  • Subject must provide written informed consent prior to any clinical investigation related procedure.
  • Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
  • Subject is scheduled to have an Abbott neurostimulation system implanted within 30 days.

Exclusion Criteria:

  • Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
  • Subject is part of a vulnerable population including incapacitated individuals, individuals unable to read or write, individuals under the age of legal consent, and pregnant or breastfeeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876054


Contacts
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Contact: Robyn Capobianco, PhD +1 512 286 4274 robyn.capobianco@abbott.com
Contact: Nicole Harbert +1 972 526 4841 nicole.harbert@abbott.com

Locations
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United States, Minnesota
Nura Recruiting
Edina, Minnesota, United States, 55435
Contact: David Schultz, MD    763-537-6000    dschultz@nuraclinics.com   
United States, Nevada
Advanced Pain Care Recruiting
Henderson, Nevada, United States, 89052
Contact: Michael Fishell, MD         
Nevada Advanced Pain Specialists Recruiting
Reno, Nevada, United States, 89511
Contact: Denis Patterson         
United States, North Carolina
Premier Pain Solutions Recruiting
Asheville, North Carolina, United States, 28803
Contact: Javid Baksh, MD         
United States, Oregon
Spinal Diagnostics Recruiting
Tualatin, Oregon, United States, 97062
Contact: Robert Heros, MD         
United States, Pennsylvania
Center for Interventional Pain and Spine Recruiting
Exton, Pennsylvania, United States, 19341
Contact: Michael Fishman, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Robyn Capobianco, PhD Abbott

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03876054     History of Changes
Other Study ID Numbers: ABT-CIP-10279
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abbott Medical Devices:
spinal cord stimulation
dorsal root ganglion stimulation
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms