Degenerative Disc DiseaseCAPREGNCT05144126
Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
A study testing CT radioraphic assessment in people with Degenerative Disc Disease, run by CeraPedics, Inc.
Trial summary
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- CT radioraphic assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Sep 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
- Informed Consent
Who cannot join
- Hypersensitivity to i-FACTOR Bone Graft Devices
- Adult Spinal deformity, Spinal Cord Injury
- Infection
- Compromised renal function
Trial locations and contacts
No sites are listed yet.
About this study
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.
Read the detailed description
The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study
- Conditions
- Degenerative Disc Disease
- Being tested
- CT radioraphic assessment
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT radioraphic assessmentOther
CT radioraphic assessment
| Study group | Role | What they receive |
|---|---|---|
| i-Factor Arm | Experimental | All patients undergoing spine fusion surgery will be treated with i-FACTOR Receives: Other: CT radioraphic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
index segment revision
Reintervention rate at index segment
Measured: 12-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CeraPedics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Talosix, Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Christopher Witiw, MD, Principal investigator, St Michael's Hosptal Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144126
- Sponsor's protocol ID
- 21/SP/COM/01
- Acronym
- CAPREG
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 3 Dec 2021
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
- ClinicalTrials.gov ID
- NCT05144126
- Acronym / sponsor ID
- CAPREG / 21/SP/COM/01
- Conditions
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CeraPedics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Talosix, Medical Metrics Diagnostics, Inc
- Study start
- Jan 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Dec 2021 (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 study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.
Detailed description
The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-Factor Arm | Experimental | Other: CT radioraphic assessmentAll patients undergoing spine fusion surgery will be treated with i-FACTOR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
- Informed Consent
Key exclusion criteria (4 listed)
- Hypersensitivity to i-FACTOR Bone Graft Devices
- Adult Spinal deformity, Spinal Cord Injury
- Infection
- Compromised renal function
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 |
|---|---|---|
| CT radioraphic assessmentCT radioraphic assessment | Other | i-Factor Arm |
Primary outcome
index segment revision
Time frame: 12-months post-operative
Reintervention rate at index segment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- 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.
Christopher Witiw, MD principal investigator
St Michael's Hosptal Toronto
Questions about this trial
What is this clinical trial studying?
A study testing CT radioraphic assessment in people with Degenerative Disc Disease, run by CeraPedics, Inc.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shankar Sivshankar, MS (+447975566265, ssivshankar@cerapedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
index segment revision (time frame: 12-months post-operative). 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 3 Dec 2021.