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

Recruiting

• Conditions: SCS

• Registration Number: NCT04548375
• Lead Sponsor: Cardio Surgical Partners

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-14
• Study Start: 2020-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain relief	12 months	Percent of patient who show a change in Pain Scale (PIPS) \>50% at the end of follow up period of 12 months

Trial Locations

Locations (1)

Summit Surgery Center; 🇺🇸 Reno, Nevada, United States