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CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Primary Purpose

Protruded Disk

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CLARIX™100

CLARIX CORD 1K

About this trial

This is an interventional treatment trial for Protruded Disk focused on measuring Discectomy, Lumbar discectomy, Protruding disc

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

CLARIX™100

CLARIX CORD 1K

Arm Description

Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions

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.

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.

Outcomes

Primary Outcome Measures

Difference in low back & leg pain

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03113786

First Posted

April 6, 2017

Last Updated

July 14, 2020

Sponsor

Amniox Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03113786

Brief Title

CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Official Title

Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

November 2, 2011 (Actual)

Primary Completion Date

April 21, 2020 (Actual)

Study Completion Date

April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amniox Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Protruded Disk

Keywords

Discectomy, Lumbar discectomy, Protruding disc

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions

Arm Title

CLARIX™100

Arm Type

Active Comparator

Arm Description

Arm Title

CLARIX CORD 1K

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

CLARIX™100

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

CLARIX CORD 1K

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in low back & leg pain

Description

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

Time Frame

5 years

Title

Difference in low back & leg pain

Description

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

Time Frame

5 years

Title

Difference in low back & leg pain

Description

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scheffer Tseng, MD, PhD

Organizational Affiliation

Tissue Tech Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Rothman Institute

City

Bensalem

State/Province

Pennsylvania

ZIP/Postal Code

19020

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

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