VIA Disc NP Registry 3.0

Back Pain Clinical Trial

Official title:

VIA Disc NP Registry 3.0

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345690
• Other study ID #: VIA-2023-003
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: VIVEX Biologics, Inc.
• Contact: Kyle Conradi
• Phone: (727) 259-9007
• Email: kyle.conradi[@]moxieclinical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Discogenic Pain
• Low Back Pain

Intervention

Other:
• VIA Disc NP
VIA Disc NP - Allograft tissue injection

Locations

Country	Name	City	State
United States	Premier Pain Solutions	Asheville	North Carolina
United States	The Orthopedic Institute	Gainesville	Florida
United States	The Denver Spine & Pain Institute	Greenwood Village	Colorado
United States	Crystal Coast Pain Management	New Bern	North Carolina
United States	Interventional Pain Specialists - Pain Clinic	Opelousas	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
VIVEX Biologics, Inc.	Moxie Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1, 3, 6, 12, & 24 months
Primary	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.	1, 3, 6, 12, & 24 months
Primary	Patient Satisfaction	Patient reported assessment of treatment using 3 different types of questions regarding their experience with the procedure.	1, 3, 6, 12, & 24 months
Primary	Pain Medication	The subject's pain medication history will be collected at the patient's baseline and follow-up visits.	1, 3, 6, 12, & 24 months