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OpenTrials
Recruiting

NCT Number: NCT04548375

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.

Recruiting

Interested in participating?

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Key information

Conditions

SCS

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

SCS

Device

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

Primary outcomes

  1. Change in pain relief

    Time frame: 12 months

    Percent of patient who show a change in Pain Scale (PIPS) >50% at the end of follow up period of 12 months

Other outcomes

  1. Sustained change of pain over the follow up period

    Time frame: 12 months

    Sustained Percentage change in Pain Scale (PIPS)>50% for the 12 month follow up period.

Study contacts

Contact information is provided by the study sponsor or research team.

tom Gordon

CONTACT

[email protected]

(513) 619-1683 ext. x5183

Sponsors and collaborators

Lead sponsor

Cardio Surgical Partners

Network

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2020
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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