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ReActiv8 Post Market Surveillance Registry

NCT ID: NCT03255200

Last Updated: 2024-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-09

Study Completion Date

2023-12-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ReActiv8 Implantable Stimulation System

Implantable electrical stimulation system.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mainstay Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Schu, MD

Role: PRINCIPAL_INVESTIGATOR

SANA Klinikum Duisburg

Locations

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Orthopadisches Krankenhaus Schloss Werneck

Werneck, Balthasar-Neumann, Germany

Site Status

BG Klinikum Bergmannstrost

Halle, , Germany

Site Status

Medizinisches Versorgungszentrum Steinburg gGmbH

Itzehoe, , Germany

Site Status

Katholisches Klinikum Koblenz

Koblenz, , Germany

Site Status

Klinikum Magdeburg

Magdeburg, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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950066

Identifier Type: -

Identifier Source: org_study_id

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