HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ReGelTec, Inc.
Study ID
NCT06011551
Status
Recruiting
Apply to this trial

Conditions

  • Degenerative Disc Disease (DDD)

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • The ReGelTec HYDRAFIL™ System — DEVICE
    The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
  • Conservative Care Management — OTHER
    Conservative care management (including physical therapy and/or pain medication)

Study Details

A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.

Key Dates

Start date
Jan 13, 2025
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")
  • Sham Comparator: Control Arm
    Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to inside the skin in the direction of the target disc(s) but without contacting the muscle layer or deeper (the "Control Arm")

Primary Outcome Measure

Composite Endpoint of Clinical Success [ Time Frame: 12-month ]

Central Contacts

  • Seth Kaufman
    443-451-3915
  • Elisa B Storyk, MPH, CCRP
    443-451-3915

Locations (13)

FacilityCityStateZIPSite coordinators
Alabama Clinical TherapeuticsBirminghamAlabama35235
Jill Andringa, RN
Bradly Goodman, MD (PRINCIPAL_INVESTIGATOR)
Source HealthcareSanta MonicaCalifornia90403
Gabriel Wirnowski
Nidhi Thati
Timothy Davis, MD (PRINCIPAL_INVESTIGATOR)
Boomerang Healthcare (IPM Medical Group)Walnut CreekCalifornia94598
Kat Abtahi
Shari Mae Santa Ana
Kasra Amirdelfan, MD (PRINCIPAL_INVESTIGATOR)
DBPS Research (The Denver Spine & Pain Institute)Greenwood VillageColorado80111
Josephine Kubik
Jake Feller
J. Scott Bainbridge, MD (PRINCIPAL_INVESTIGATOR)
The Orthopaedic InstituteGainesvilleFlorida32607
Aldrin Yumul
Ajay Antony, MD (PRINCIPAL_INVESTIGATOR)
Southwest Florida Pain CenterPort CharlotteFlorida33948
Marie Zambelli, APRN-FNP
Robert Ball, DO, MS (PRINCIPAL_INVESTIGATOR)
NRSA Group (Florida Spine & Pain Specialists)RiverviewFlorida33569
Rachel Gelch
Nomen Azeem, MD, FAAPMR (PRINCIPAL_INVESTIGATOR)
Horizon Clinical Research (Southern Pain and Spine)JasperGeorgia30143
Julianna Kirby
Jordan L. Tate, MD, MPH (PRINCIPAL_INVESTIGATOR)
Neuroscience Research Center, LLCOverland ParkKansas66210
Amy Reinert, BS
Mayank Gupta, MD (PRINCIPAL_INVESTIGATOR)
Spine Institute of Louisiana (The Spine Network)ShreveportLouisiana71101
Krista Kachnik, BS, ACRP-CP
Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR)
Clinical InvestigationsEdmondOklahoma73103
Jennifer Witherby, BSN, RN
Douglas Beall, MD (PRINCIPAL_INVESTIGATOR)
Precision Spine CareTylerTexas75701
Gabriela Salazar
Aaron Calodney, MD (PRINCIPAL_INVESTIGATOR)
Virginia iSpine PhysiciansRichmondVirginia23238
Devon Withers
Jack Davis
Michael J. DePalma, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics· Birmingham, ALSource Healthcare· Santa Monica, CABoomerang Healthcare (IPM Medical Group)· Walnut Creek, CADBPS Research (The Denver Spine & Pain Institute)· Greenwood Village, COThe Orthopaedic Institute· Gainesville, FLSouthwest Florida Pain Center· Port Charlotte, FL

Related Studies