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CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113786
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Amniox Medical, Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE November 2, 2011
Actual Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Difference in low back & leg pain [ Time Frame: 5 years ]
    To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the Oswestry Disability Index scales for both back & leg pain
  • Difference in low back & leg pain [ Time Frame: 5 years ]
    To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the SF-12 scale for both back & leg pain
  • Difference in low back & leg pain [ Time Frame: 5 years ]
    To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the VAS for both back & leg pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
Official Title  ICMJE Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Protruded Disk
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions
  • Active Comparator: CLARIX™100
    Subjects randomized to the CLARIX™100 arm will undergo a traditional lumbar discectomy, after which CLARIX™100 will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.
    Intervention: Other: CLARIX™100
  • Active Comparator: CLARIX CORD 1K
    Subjects randomized to the CLARIX CORD 1K arm will undergo a traditional lumbar discectomy, after which CLARIX CORD 1K will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.
    Intervention: Other: CLARIX CORD 1K
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
120
Actual Study Completion Date  ICMJE April 21, 2020
Actual Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients between 18 and 90 years of age
  • Patient is able to understand the aims and objectives of the trial and the trial procedures
  • Patient is willing to give written informed consent to the trial
  • Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff
  • Diagnosed with lumbar protruding disc
  • Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options

Exclusion Criteria:

  • Participation in clinical trial involving therapy for back pain within 30 days of screening
  • Prior back surgery at the same level
  • Inability to walk independently (adaptive devices such as walkers or canes are allowed)
  • Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company
  • Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit
  • Pregnancy or planning to become pregnant during study period
  • Body Mass Index >50
  • Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema
  • Severe anemia, hemoglobin <8.5 mg/dL
  • Active, local or systemic malignancy such as lung cancer or leukemia
  • Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg)
  • Severe hypoxia, with chronic oxygen or ventilation therapy
  • History of collagen vascular disease or sickle cell anemia
  • Active rheumatoid arthritis
  • Systemic antibiotic therapy for any indication within 10 days of screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03113786
Other Study ID Numbers  ICMJE CR-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Amniox Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amniox Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Scheffer Tseng, MD, PhD Tissue Tech Inc.
PRS Account Amniox Medical, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP