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VIA Disc NP Registry 3.0

VIA Disc NP Registry 3.0

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06345690
Enrollment
500
Registered
2024-04-03
Start date
2024-02-27
Completion date
2027-01-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Back Pain, Low, Discogenic Pain

Keywords

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.

Interventions

VIA Disc NP - Allograft tissue injection

Sponsors

VIVEX Biologics, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scale (NPRS)1, 3, 6, & 12 monthsChange in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Oswestry Disability Index (ODI)1, 3, 6, & 12 monthsChange in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Patient Satisfaction1, 3, 6, & 12 monthsPatient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best).
Frequency of Pain Medication Use1, 3, 6, & 12 monthsAssesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time.

Countries

United States

Contacts

STUDY_DIRECTORLeslie Zaccari

Sponsor - Vivex Biologics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026