Trials / Completed
CompletedNCT03113786
CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Amniox Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | CLARIX™100 | CLARIX™100 is Amniox's processed and cryopreserved human amniotic membrane tissue retrieved from donated placental tissue after elective Cesarean Section delivery. Amniox's Amniotic Membrane is designated by the FDA as a tissue product under PHS 361 HCT/P (human cells, tissues and cellular and tissue-based products). |
| OTHER | CLARIX CORD 1K | CLARIX CORD 1K is made from cryopreserved human umbilical cord, utilizing the patented CRYOTEK™ process. CLARIX CORD 1K is considered a Human Cells, Tissues \& Cellular and Tissue-based product (HCT/P) by U.S. FDA standards. |
Timeline
- Start date
- 2011-11-02
- Primary completion
- 2020-04-21
- Completion
- 2020-04-21
- First posted
- 2017-04-14
- Last updated
- 2020-07-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03113786. Inclusion in this directory is not an endorsement.