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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548375
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Cardio Surgical Partners

Study Description
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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.

Condition or disease Intervention/treatment
SCS 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023
Groups and Cohorts
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Intervention Details:
  • Device: SCS
    Conventional SCS implants approved through all payors(government and private) for FDA approved indications

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All SCS implants
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548375


Contacts
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Contact: tom Gordon (513) 619-1683 ext x5183 tom.gordon@advarra.com

Locations
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United States, Nevada
Summit Surgery Center Recruiting
Reno, Nevada, United States, 89511
Contact: Deb M    775-674-5200    debm@summit.org   
Sponsors and Collaborators
Cardio Surgical Partners
More Information
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Responsible Party: Cardio Surgical Partners
ClinicalTrials.gov Identifier: NCT04548375    
Other Study ID Numbers: PainReg
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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