NCT04548375

Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cardio Surgical Partners · Network
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.

Detailed description

This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.

Conditions

• SCS

Interventions

Type	Name	Description
DEVICE	SCS	Conventional SCS implants approved through all payors(government and private) for FDA approved indications

Timeline

• Start date: 2020-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2020-09-14
• Last updated: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study