Prospective data collection to evaluate the feedback control of the Saluda Medical's EvokeTM Spinal Cord Stimulation System in the treatment of patients with chronic pain of the trunk and/or limbs.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29510

Enrollment

150

Registered

2019-07-22

Start date

2019-07-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain in the trunk and/or limbs

Interventions

This prospective data collection is purely observational and does not include any intervention.

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects Age 18 and older Suffering from chronic pain in trunk and/or limbs Routinely scheduled for SCS with Saluda Medical System Subject approval for prospective data collection and transfer of de-identified data to Saluda Medical

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

Measure	Time frame
Collection of electrophysiological and device data from the EvokeTM Closed-Loop SCS system in the treatment of chronic pain of trunk and/or limbs, in a 'real world' setting under normal clinical use.	—

Secondary

Measure	Time frame
To evaluate any prognostic indicators from the electrophysiological and device data in combination with basic demographic and outcome data. To evaluate 'real world' usability of the EvokeTM Closed Loop SCS System.	—

Contacts

Public ContactCarin Wensing

Saluda Medical

carin.wensing@saludamedical.com+44 1423 547 229

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)