VIA Disc NP Registry 3.0

N/ARecruitingNCT06345690

VIVEX Biologics, Inc.500 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Discogenic Pain Back Pain Back Pain, Low

Interventions

VIA Disc NPOTHER

VIA Disc NP - Allograft tissue injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

Numeric Pain Rating Scale (NPRS)

Change 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).

Time frame: 1, 3, 6, & 12 months

Oswestry Disability Index (ODI)

Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.

Time frame: 1, 3, 6, & 12 months

Patient Satisfaction

Patient 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).

Time frame: 1, 3, 6, & 12 months

Frequency of Pain Medication Use

Assesses 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.

Time frame: 1, 3, 6, & 12 months

Central Contacts

Leslie Zaccari

CONTACT

714-366-6457 lzaccari@vivex.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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