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CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

NCT03113786 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-07-15

No results posted yet for this study

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

  • Protruded Disk

Interventions

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.

Sponsors & Collaborators

  • Amniox Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Scheffer Tseng, MD, PhD · BioTissue Holdings, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-02
Primary Completion
2020-04-21
Completion
2020-04-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113786 on ClinicalTrials.gov