NCT04548375

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2020Nov 2026

First Submitted

Initial submission to the registry

August 26, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

6 years

First QC Date

August 26, 2020

Last Update Submit

August 19, 2024

Conditions

SCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sustained change of pain over the follow up period

    12 months

Interventions

SCSDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All SCS implants

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summit Surgery Center

Reno, Nevada, 89511, United States

RECRUITING

Central Study Contacts

tom Gordon

CONTACT

(513) 619-1683tom.gordon@advarra.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 14, 2020

Study Start

November 1, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)