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Active, Not Recruiting

NCT Number: NCT06345690

VIA Disc NP Registry 3.0

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Discogenic Pain Back Pain Back Pain, Low Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mocek Spine, Little Rock, Arkansas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

VIA Disc NP

Other

VIA Disc NP - Allograft tissue injection

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

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

    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).

  2. Oswestry Disability Index (ODI)

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

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

  3. Patient Satisfaction

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

    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).

  4. Frequency of Pain Medication Use

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

    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.

Sponsors and collaborators

Lead sponsor

VIVEX Biologics, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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