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 (Domburg)

Saluda Medical

Status: Active, not recruiting

Conditions: Chronic Pain

Treatments: Device: Evoke Spinal Cord Stimulation (SCS) System

Study type: Observational

Funder types: Industry

Identifiers

NCT04627974

CLIN-PLC-005299

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

ECAP-controlled, closed-loop SCS

Description:

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Treatment:

Device: Evoke Spinal Cord Stimulation (SCS) System