Protruded DiskPhase 4NCT03113786
CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
A Phase 4 study testing CLARIX™100 and CLARIX CORD 1K in people with Protruded Disk, run by Amniox Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Protruded Disk
- What is being tested?
- CLARIX™100 and CLARIX CORD 1K
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2011to 21 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CLARIX™100, CLARIX CORD 1K
- Keywords
- Discectomy, Lumbar discectomy, Protruding disc
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLARIX™100Other
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).
CLARIX CORD 1KOther
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 group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions |
| CLARIX™100 | Active comparator | 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. Receives: Other: CLARIX™100 |
| CLARIX CORD 1K | Active comparator | 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. Receives: Other: CLARIX CORD 1K |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start2 Nov 2011
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protruded DiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amniox Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scheffer Tseng, MD, PhD, Study chair, BioTissue Holdings, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113786
- Sponsor's protocol ID
- CR-1001
- Status last verified
- Jul 2020
- First submitted
- 6 Apr 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03113786
- Acronym / sponsor ID
- CR-1001
- Conditions
- Protruded Disk
- Keywords
- Discectomy, Lumbar discectomy, Protruding disc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Amniox Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2011 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions |
| CLARIX™100 | Active comparator | Other: CLARIX™100Subjects 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. |
| CLARIX CORD 1K | Active comparator | Other: CLARIX CORD 1KSubjects 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLARIX™100CLARIX™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™100 |
| CLARIX CORD 1KCLARIX 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. | Other | CLARIX CORD 1K |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scheffer Tseng, MD, PhD study chair
BioTissue Holdings, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CLARIX™100 and CLARIX CORD 1K in people with Protruded Disk, run by Amniox Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in low back & leg pain (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.