Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-02-27
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
VIA Disc NP
VIA Disc NP - Allograft tissue injection
Interventions
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VIA Disc NP
VIA Disc NP - Allograft tissue injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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VIVEX Biologics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Leslie Zaccari
Role: STUDY_DIRECTOR
Sponsor - Vivex Biologics
Locations
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Mocek Spine
Little Rock, Arkansas, United States
MD Pain
Englewood, Colorado, United States
Western Rockies Interventional Pain
Grand Junction, Colorado, United States
The Denver Spine & Pain Institute
Greenwood Village, Colorado, United States
Premier Spine and Pain Institute
Thornton, Colorado, United States
The Orthopedic Institute
Gainesville, Florida, United States
Raso Pain Center
Jupiter, Florida, United States
Interventional Spine Care of the Palm Beaches
West Palm Beach, Florida, United States
Horizon Clinical Research
Jasper, Georgia, United States
The Orthopedic Research Foundation, Inc.
Fishers, Indiana, United States
Interventional Pain Specialists - Pain Clinic
Opelousas, Louisiana, United States
Paradigm Health System
Slidell, Louisiana, United States
Premier Pain Solutions
Asheville, North Carolina, United States
Comprehensive Pain Consultants of the Carolinas
Hendersonville, North Carolina, United States
Crystal Coast Pain Management
Morehead City, North Carolina, United States
Crystal Coast Pain Management
New Bern, North Carolina, United States
Align Interventional Pain
Edmond, Oklahoma, United States
Fox Chase Pain Management_Delaware Valley Pain and Spine Institute (DVPSI)
Trevose, Pennsylvania, United States
Atlantic Coast Spine & Pain
Conway, South Carolina, United States
Renew Pain Solutions
Greenville, South Carolina, United States
Specialists in Pain Managment
Chattanooga, Tennessee, United States
Freedom Spine
Boerne, Texas, United States
Corpus Chrisi Pain Medicine
Corpus Christi, Texas, United States
Advanced Spine and Pain Center
San Antonio, Texas, United States
Pain and Wellness Institute of Texas
Spring Branch, Texas, United States
Precision Spine Care
Tyler, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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J. Taylor Mansfield, DO
Role: primary
Other Identifiers
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VIA-2023-003
Identifier Type: -
Identifier Source: org_study_id
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