Middle Ear DiseaseNCT03297736
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
A study testing 3D CAD/CAM autograft prosthesis in people with Middle Ear Disease, run by Nitinetics LLC at 1 site in United States.
Trial summary
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Middle Ear Disease
- What is being tested?
- 3D CAD/CAM autograft prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Who cannot join
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
Alisa Knox contact
United States1 site, 1 recruiting
- Recruiting
University of Florida-Jacksonville
Jacksonville, Florida, 32209
Glenn Knox, M.D., J.D., 904-244-3498, Glenn.Knox@jax.ufl.edu
About this study
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.
Read the detailed description
Conventional middle ear prosthetic prosthetics, including total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive, require large inventories for otologic surgery services, and carry the risk of extrusion or rejection. Autologous bone and cartilage can be used for many of these applications, but it requires expensive operating room time for carving to the appropriate shape and size.
The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted design/computer assisted manufacture) to produce accurate bone and cartilage autografts on demand in the operating room. Such a technology is hypothesized to save money by reducing operating room time, and reducing the need for expensive inventories of various shapes, sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be less likely to extrude or cause other problems such as infection, this could also reduce costs.
- Conditions
- Middle Ear Disease
- Being tested
- 3D CAD/CAM autograft prosthesis, Control device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D CAD/CAM autograft prosthesisDevice
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
Control deviceDevice
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects receive the control device. Receives: Device: Control device |
| Investigational device | Experimental | Subject receives the 3D CAD/CAM autograft prosthesis implant. Receives: Device: 3D CAD/CAM autograft prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost savings
operative costs compared between treatment groups utilizing total operative time in minutes
Measured: perioperative
Secondary outcomes (3)
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
infectious process involving the use of a medical device
Measured: 6 months
ABG
mean air-bone gap assessed and compared between treatment groups for statistical significance
Measured: preoperative; 6weeks, 3 months, and 6 months postoperatively.
Number of participants that experience device rejection
rejection of device/prosthesis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Mar 2016
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitinetics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Knox, M.D., J.D., Principal investigator, Nitinetics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297736
- Sponsor's protocol ID
- 3D CAD/CAM
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2017
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
- ClinicalTrials.gov ID
- NCT03297736
- Acronym / sponsor ID
- 3D CAD/CAM
- Conditions
- Middle Ear Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nitinetics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Sep 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.
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.
Detailed description
Conventional middle ear prosthetic prosthetics, including total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive, require large inventories for otologic surgery services, and carry the risk of extrusion or rejection. Autologous bone and cartilage can be used for many of these applications, but it requires expensive operating room time for carving to the appropriate shape and size.
The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted design/computer assisted manufacture) to produce accurate bone and cartilage autografts on demand in the operating room. Such a technology is hypothesized to save money by reducing operating room time, and reducing the need for expensive inventories of various shapes, sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be less likely to extrude or cause other problems such as infection, this could also reduce costs.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Control deviceSubjects receive the control device. |
| Investigational device | Experimental | Device: 3D CAD/CAM autograft prosthesisSubject receives the 3D CAD/CAM autograft prosthesis implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Key exclusion criteria (1 listed)
- congenital anomalies
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 |
|---|---|---|
| 3D CAD/CAM autograft prosthesisSurgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM. | Device | Investigational device |
| Control deviceSurgical ossicular reconstruction with the standard available middle ear prosthesis. | Device | Control |
Primary outcome
Cost savings
Time frame: perioperative
operative costs compared between treatment groups utilizing total operative time in minutes
3 secondary outcomes
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
ABG
Time frame: preoperative; 6weeks, 3 months, and 6 months postoperatively.
Number of participants that experience device rejection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
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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.
Alisa Knox contact
Glenn Knox, M.D., J.D. principal investigator
Nitinetics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D CAD/CAM autograft prosthesis in people with Middle Ear Disease, run by Nitinetics LLC 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 1 inclusion and 1 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 24 Sep 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.
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 Glenn Knox, M.D., J.D. ((904) 244-3498, Glenn.Knox@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost savings (time frame: perioperative). 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 24 Sep 2020.