Clinical trial NCT04652687: VIA Disc NP Registry
Official title: VIA Disc NP Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Discogenic Pain
Back Pain
Back Pain, Low
Keywords: back pain
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registry will include at least 10,000 patients diagnosed with and treated for back pain across approximately 200 selected sites.

Brief summary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

Detailed description: The Registry is intended to collect data for patients having received treatment with VIA Disc NP.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Understand and sign the informed consent form (as applicable)
* VIA Disc NP injection is scheduled for 1 or more levels

Exclusion Criteria:

* VIA Disc NP injection is not performed

Primary outcomes:
measure: Patient self-reporting of daily function
timeFrame: 1, 3, 6, 12, 24, & 36 months
measure: Patient self-reported back pain
timeFrame: 1, 3, 6, 12, 24, & 36 months
Secondary outcomes:
measure: Patient self-reported mental health
timeFrame: 1, 3, 6, 12, 24, & 36 months
measure: Resource Utilization
timeFrame: 1, 3, 6, 12, 24, & 36 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Gateway Pain Solutions
state: Arizona
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Walnut Creek
country: United States
facility: Interventional Pain Management
state: California
city: Englewood
country: United States
facility: MD Pain
state: Colorado
city: Grand Junction
country: United States
facility: Western Rockies Interventional Pain Specialists
state: Colorado
city: Greenwood Village
country: United States
facility: The Denver Spine & Pain Institute
state: Colorado
city: Washington
country: United States
facility: International Spine, Pain & Performance Center
state: District of Columbia
city: Gainesville
country: United States
facility: The Orthopedic Institute
state: Florida
city: Port Charlotte
country: United States
facility: Southwest Florida Pain Center
state: Florida
city: Tampa
country: United States
facility: FAST MD
state: Florida
city: Tampa
country: United States
facility: Florida Spine & Pain Specialists
state: Florida
city: Wesley Chapel
country: United States
facility: Florida Pain Medicine
state: Florida
city: Indianapolis
country: United States
facility: Orthopaedic Research Foundation
state: Indiana
city: Lafayette
country: United States
facility: Anesthesiology & Pain Consultants
state: Louisiana
city: Opelousas
country: United States
facility: Interventional Pain Specialists
state: Louisiana
city: Brownstown
country: United States
facility: Michigan Interventional Pain Center
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Health
state: Michigan
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Asheville
country: United States
facility: Premier Pain Solutions
state: North Carolina
city: New Bern
country: United States
facility: Crystal Coast Pain Management
state: North Carolina
city: Loveland
country: United States
facility: Premier Pain
state: Ohio
city: Tulsa
country: United States
facility: Invictus Healthcare System
state: Oklahoma
city: Chadds Ford
country: United States
facility: Center for Interventional Pain Spine
state: Pennsylvania
city: Conway
country: United States
facility: Atlantic Coast Pain Management
state: South Carolina
city: Mount Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
city: Chattanooga
country: United States
facility: Specialist in Pain Management
state: Tennessee
city: Franklin
country: United States
facility: Vertex Spine
state: Tennessee
city: North Richland Hills
country: United States
facility: Ortho Spine Surgery Institute
state: Texas
city: San Antonio
country: United States
facility: MD SpineCare and DC Medical Solutions
state: Texas
city: San Antonio
country: United States
facility: Advanced Spine and Pain Center
state: Texas
city: Shenandoah
country: United States
facility: The Sprintz Center for Pain
state: Texas
Study officials:
affiliation: Vivex Biologics
name: Lisa Finstein, MHA
role: STUDY_DIRECTOR
References: