- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272137
Evoke Data Collection Study Germany
April 10, 2023 updated by: Saluda Medical Pty Ltd
Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical's Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angela Leitner, MS
- Phone Number: 651-208-4223
- Email: angela.leitner@saludamedical.com
Study Locations
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Germany, 40225
- Universität Düsseldorf
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.
Description
Inclusion Criteria:
- Patient approval for data collection and transfer of de-identified data to sponsor.
Exclusion Criteria:
- No further exclusion criteria.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ECAP-controlled, closed-loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
|
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ECAP Measurement in Microvolts
Time Frame: through 6 months post-implant
|
Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation
|
through 6 months post-implant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 4, 2022
Primary Completion (Actual)
October 17, 2022
Study Completion (Actual)
October 17, 2022
Study Registration Dates
First Submitted
January 13, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 9, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D100967
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Washington University School of MedicineCompletedHip Pain Chronic | Back Pain | Chronic Pain | Knee Pain ChronicUnited States
Clinical Trials on Evoke Spinal Cord Stimulation (SCS) System
-
Saluda Medical Americas, Inc.CompletedPain | Back Pain | Chronic PainUnited States
-
Imperial College LondonRecruitingParkinson Disease | Freezing of GaitUnited Kingdom
-
Saluda Medical Pty LtdRecruitingChronic PainAustralia
-
Saluda Medical Pty LtdRecruiting
-
Saluda Medical Pty LtdActive, not recruitingChronic PainUnited Kingdom, Netherlands, Germany, Belgium
-
Boston Scientific CorporationCompletedPain | Neuropathic PainUnited States
-
Saint Francis HospitalSaluda Medical Americas, Inc.RecruitingPain | Chronic Pain | Neuropathic PainUnited States
-
Boston Scientific CorporationCompletedChronic PainUnited Kingdom, Germany, Italy, Netherlands
-
St. Olavs HospitalNorwegian University of Science and TechnologyRecruiting
-
MedtronicNeuroCompleted