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

SCS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548375
• Other study ID #: PainReg
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: Cardio Surgical Partners
• Contact: tom Gordon
• Phone: (513) 619-1683
• Email: tom.gordon[@]advarra.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• SCS

Intervention

Device:
• SCS
Conventional SCS implants approved through all payors(government and private) for FDA approved indications

Locations

Country	Name	City	State
United States	Summit Surgery Center	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Cardio Surgical Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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