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

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.

Study Overview

• Status: Recruiting
• Conditions: SCS
• Intervention / Treatment: Device: SCS

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: tom Gordon; Phone Number: x5183 (513) 619-1683; Email: tom.gordon@advarra.com

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89511
      • Recruiting
      • Summit Surgery Center
      • Contact: Deb M; Phone Number: 775-674-5200; Email: debm@summit.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All SCS implants

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained change of pain over the follow up period	Sustained Percentage change in Pain Scale (PIPS)>50% for the 12 month follow up period.	12 months

Collaborators and Investigators

• Sponsor: Cardio Surgical Partners

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PainReg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No