Domburg: Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

• Sponsor: Saluda Medical Pty Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04627974
• Collaborator: (none)
• Enrollment: 70
• Locations: 7
• Anticipated Duration (Months): 85.8
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Evoke Spinal Cord Stimulation (SCS) System

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
• Actual Study Start Date: Aug 5, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	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	Device: Evoke Spinal Cord Stimulation (SCS) System; 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

Outcome Measures

Primary Outcome Measures

1. Percent Change in Visual Analogue Scale (VAS) Pain [3-months post-implant]

   Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])

Secondary Outcome Measures

1. Incidence of device- and procedure-related adverse events [through 60-months post-implant]

2. Measurement of ECAPs by the Evoke SCS System [through 60-months post-implant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eligible for therapy according to the Evoke System indications for use statement and labelling requirements

• Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits

• Baseline VAS pain rating ≥60 mm in the primary area of pain

Exclusion Criteria:

• No further exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Nikolaas Multidisciplinary Pain Center	Sint-Niklaas	East Flanders	Belgium	9100
2	AZ Delta Multidisciplinary Pain Center	Roeselare	West Flanders	Belgium	8800
3	Erasmus University Medical Center	Rotterdam		Netherlands	3015 GD
4	Rijnstate	Velp		Netherlands	6815 AD
5	Basildon University Hospital	Basildon	Essex	United Kingdom	SS16 5NL
6	James Cook University Hospital	Middlesbrough	North Yorkshire	United Kingdom	TS4 3BW
7	Southmead Hospital	Bristol		United Kingdom	BS10 5NB

Sponsors and Collaborators

• Saluda Medical Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saluda Medical Pty Ltd
• ClinicalTrials.gov Identifier: NCT04627974
• Other Study ID Numbers: CLIN-PLC-005299
• First Posted: Nov 13, 2020
• Last Update Posted: Jan 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Jan 14, 2022