Multicenter Outcome Registry of AnaLgesic Effect of SCS(M... | NCT04548375

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

NCT04548375

Sponsor

Cardio Surgical Partners

Status

Recruiting

Last Update Posted

Aug 20, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Sep 9, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCS	Device	Conventional SCS implants approved through all payors(government and private) for FDA approved indications

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All SCS implants

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
tom Gordon	Contact	(513) 619-1683	x5183	tom.gordon@advarra.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Summit Surgery Center	Recruiting	Reno	Nevada	89511	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided