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Trial record 9 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

ReActiv8 Post Market Surveillance Registry (ReActiv8-C)

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ClinicalTrials.gov Identifier: NCT03255200
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mainstay Medical

Brief Summary:
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.

Condition or disease Intervention/treatment
Chronic Low Back Pain Device: ReActiv8 Implantable Stimulation System

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain


Intervention Details:
  • Device: ReActiv8 Implantable Stimulation System
    Implantable electrical stimulation system.


Primary Outcome Measures :
  1. Low Back Pain - NRS [ Time Frame: 90 days, 180 days, 1 year, 2 years post Activation ]
    Change in NRS compared to Baseline


Secondary Outcome Measures :
  1. Serious Adverse Device Effects [ Time Frame: Through 2 years post Activation ]


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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.
Criteria

Inclusion Criteria:

  1. Meet the Indications for ReActiv8
  2. Willing to sign the Informed Consent for the Registry
  3. Age ≥ 18 years

Exclusion Criteria:

1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.


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): NCT03255200


Contacts
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Contact: Diane Burnside +1 763 270 5303 diane.burnside@mainstay-medical.com

Locations
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Germany
Uni Bonn Recruiting
Bonn, Germany
Principal Investigator: Dr. Robert Pflugmacher         
SANA Klinikum Duisburg Not yet recruiting
Duisburg, Germany
Principal Investigator: Dr. Stefan Schu         
BG Klinikum Bergmannstrost Recruiting
Halle, Germany
Principal Investigator: Prof. Dr. Hans-Jörg Meisel         
Tabea Krankenhaus Hamburg Recruiting
Hamburg, Germany
Principal Investigator: Dr. Jan Schilling         
Medizinisches Versorgungszentrum Steinburg gGmbH Recruiting
Itzehoe, Germany
Principal Investigator: Dr. Ardeshir Ardeshiri         
Katholisches Klinikum Koblenz Recruiting
Koblenz, Germany
Principal Investigator: Dr. Francis Killian         
Klinikum Magdeburg Recruiting
Magdeburg, Germany
Principal Investigator: Dr. Jörg Franke         
Sponsors and Collaborators
Mainstay Medical
Investigators
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Principal Investigator: Stefan Schu, MD SANA Klinikum Duisburg

Additional Information:

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Responsible Party: Mainstay Medical
ClinicalTrials.gov Identifier: NCT03255200     History of Changes
Other Study ID Numbers: 950066
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms