Clinical trial NCT06345690: VIA Disc NP Registry 3.0
Official title: VIA Disc NP Registry 3.0
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Discogenic Pain
Back Pain
Back Pain, Low
Keywords: Back Pain
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Moxie Clinical
First posted: 2024-04-03
Enrollment: 500
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: Participants diagnosed with and treated for back pain.

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:

1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
2. 18 years of age or older
3. Literate, able to speak and read English, and able to complete questionnaires independently
4. Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.

Exclusion Criteria:

1. Participant did not receive VIA Disc NP injection
2. Participant is pregnant (self-reported, no special study pregnancy testing needed).
3. Any contraindications as noted in the VIA Disc NP Instructions for Use
4. Previous treatment with VIA Disc NP

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 1, 3, 6, & 12 months
measure: Oswestry Disability Index (ODI)
timeFrame: 1, 3, 6, & 12 months
measure: Patient Satisfaction
timeFrame: 1, 3, 6, & 12 months
measure: Frequency of Pain Medication Use
timeFrame: 1, 3, 6, & 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Mocek Spine
state: Arkansas
city: Englewood
country: United States
facility: MD Pain
state: Colorado
city: Grand Junction
country: United States
facility: Western Rockies Interventional Pain
state: Colorado
city: Greenwood Village
country: United States
facility: The Denver Spine & Pain Institute
state: Colorado
city: Thornton
country: United States
facility: Premier Spine and Pain Institute
state: Colorado
city: Gainesville
country: United States
facility: The Orthopedic Institute
state: Florida
city: Jupiter
country: United States
facility: Raso Pain Center
state: Florida
city: West Palm Beach
country: United States
facility: Interventional Spine Care of the Palm Beaches
state: Florida
city: Jasper
country: United States
facility: Horizon Clinical Research
state: Georgia
city: Fishers
country: United States
facility: The Orthopedic Research Foundation, Inc.
state: Indiana
city: Opelousas
country: United States
facility: Interventional Pain Specialists - Pain Clinic
state: Louisiana
city: Slidell
country: United States
facility: Paradigm Health System
state: Louisiana
city: Asheville
country: United States
facility: Premier Pain Solutions
state: North Carolina
city: Hendersonville
country: United States
facility: Comprehensive Pain Consultants of the Carolinas
state: North Carolina
city: Huntsville
country: United States
facility: Carolinas Pain Center
state: North Carolina
city: Morehead City
country: United States
facility: Crystal Coast Pain Management
state: North Carolina
city: New Bern
country: United States
facility: Crystal Coast Pain Management
state: North Carolina
city: Greenville
country: United States
facility: Renew Pain Solutions
state: South Carolina
city: Corpus Christi
country: United States
facility: Corpus Chrisi Pain Medicine
state: Texas
city: San Antonio
country: United States
facility: Advanced Spine and Pain Center
state: Texas
city: Shenandoah
country: United States
facility: Procura Pain & Spine
state: Texas
city: Spring
country: United States
facility: Woodlands Pain Consultants
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: cro
name: Jasmine Wilson
role: STUDY_DIRECTOR
References: