RECRUITING

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

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Conditions

Chronic Painspinal cord stimulationdorsal root ganglion stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Official Title

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

Quick Facts

Study Start:2019-03-13
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03876054

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject must provide written informed consent prior to any clinical investigation related procedure.
  2. 2. 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.
  3. 3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
  4. 4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
  1. 1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  2. 2. 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.
  3. 3. Subject has or is scheduled to receive an intrathecal pump.
  4. 4. Subject is part of a vulnerable population.
  5. 5. Subject has an existing implanted neuromodulation device to address their chronic pain.

Contacts and Locations

Study Contact

Bram Blomme
CONTACT
+32 474 74 83 10
bram.blomme@abbott.com
Jenny Qin
CONTACT
+1 917-349-0779
jenny.qin@abbott.com

Principal Investigator

Devyani Nanduri
STUDY_DIRECTOR
Abbott Medical Devices Neuromodulation

Study Locations (Sites)

Phoenician Centers for Research & Innovation
Phoenix, Arizona, 85021
United States
Pain Institute of Southern Arizona
Tucson, Arizona, 85718
United States
California Orthopedics & Spine
Larkspur, California, 94939
United States
Restore Orthopedics & Spine Center
Orange, California, 92868
United States
Foothills Pain Management Clinic
Pomona, California, 91767
United States
Pacific Research Institute
Santa Rosa, California, 95403
United States
University of Florida Department of Anesthesia
Gainesville, Florida, 32610
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Chicago
Chicago, Illinois, 60637
United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46032
United States
Nura
Edina, Minnesota, 55435
United States
Twin Cities Pain Clinic
Edina, Minnesota, 55439
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Saint Louis Pain Consultants
Chesterfield, Missouri, 63017
United States
Advanced Pain Care
Henderson, Nevada, 89052
United States
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
United States
Ainsworth Institute of Pain Management
New York, New York, 10022
United States
Unity Spine Center
Rochester, New York, 14626
United States
The Spine & Pain Institute of New York
Staten Island, New York, 10305
United States
Premier Pain Solutions
Asheville, North Carolina, 28803
United States
Adena Bone and Joint Center
Chillicothe, Ohio, 45601
United States
Premier Pain Treatment Institute
Loveland, Ohio, 45140
United States
Pacific Sports & Spine
Eugene, Oregon, 97401
United States
Spinal Diagnostics
Tualatin, Oregon, 97062
United States
Center for Interventional Pain & Spine
Exton, Pennsylvania, 19341
United States
Expert Pain
Houston, Texas, 77079
United States
Central Texas Pain Institute
Killeen, Texas, 76542
United States
Integrated Pain Associates
Killeen, Texas, 76542
United States
Advanced Pain Care
Round Rock, Texas, 78664
United States
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, 25301
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Devyani Nanduri, STUDY_DIRECTOR, Abbott Medical Devices Neuromodulation

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 Registration Dates

Study Start Date2019-03-13
Study Completion Date2029-12

Study Record Updates

Study Start Date2019-03-13
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • spinal cord stimulation
  • dorsal root ganglion stimulation

Additional Relevant MeSH Terms

  • Chronic Pain