Hearing LossPCI-INCT01460823
Percutaneous Cochlear Implantation: Implementation of Technique
A study testing Percutaneous Cochlear Implantation using image guided surgical techniques in people with Hearing Loss, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Percutaneous Cochlear Implantation using image guided surgical techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 year old patients undergoing cochlear implantation who are able to participate in the informed consent process.
- Pre-operative CT scan of head performed as standard of care for cochlear implant work-up.
Who cannot join
- Patients with co-morbidities so severe that the potential additional operating room time is deemed to be too significant of an operative risk. This assessment is made by the local institutions pre-operative work-up.
- History of allergic reaction/intolerance of local anesthesia and/or epinephrine.
- History of allergic reaction to titanium.
- Patients with severe anatomical abnormality of the temporal bone.
- Patients with severe chronic ear disease for whom traditional mastoidectomy might offer benefit.
- Females who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.
- Conditions
- Hearing Loss
- Being tested
- Percutaneous Cochlear Implantation using image guided surgical techniques
- Keywords
- Hearing loss, Cochlear Implantation, Image guided surgery
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Cochlear Implantation using image guided surgical techniquesProcedure or surgery
Percutaneous Cochlear Implantation using image guided surgical techniques.
| Study group | Role | What they receive |
|---|---|---|
| Use of image guided surgery | Experimental | Not described Receives: Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
A successful percutaneous cochlear implantation is one where the facial nerve was not damaged during the procedure and the surgeon did not resort back to the standard implantation method. We will measure the percentage of participants who underwent successful cochlear implantation via the percutaneous method.
Measured: Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionJul 2014
Why it stopped: Currently in the process of submitting IDE to the FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F. Labadie, Vanderbilt University
- Investigators
- Robert F. Labadie, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460823
- Sponsor's protocol ID
- 111114
- Acronym
- PCI-I
- Status last verified
- Dec 2014
- First submitted
- 24 Oct 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cochlear Implantation: Implementation of Technique
- ClinicalTrials.gov ID
- NCT01460823
- Acronym / sponsor ID
- PCI-I / 111114
- Conditions
- Hearing Loss
- Keywords
- Hearing loss, Cochlear Implantation, Image guided surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Currently in the process of submitting IDE to the FDA
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Oct 2011 (estimated)
- 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 investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of image guided surgery | Experimental | Procedure: Percutaneous Cochlear Implantation using image guided surgical techniques |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 year old patients undergoing cochlear implantation who are able to participate in the informed consent process.
- Pre-operative CT scan of head performed as standard of care for cochlear implant work-up.
Key exclusion criteria (6 listed)
- Patients with co-morbidities so severe that the potential additional operating room time is deemed to be too significant of an operative risk. This assessment is made by the local institutions pre-operative work-up.
- History of allergic reaction/intolerance of local anesthesia and/or epinephrine.
- History of allergic reaction to titanium.
- Patients with severe anatomical abnormality of the temporal bone.
- Patients with severe chronic ear disease for whom traditional mastoidectomy might offer benefit.
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 |
|---|---|---|
| Percutaneous Cochlear Implantation using image guided surgical techniquesPercutaneous Cochlear Implantation using image guided surgical techniques. | Procedure or surgery | Use of image guided surgery |
Primary outcome
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
Time frame: Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.
A successful percutaneous cochlear implantation is one where the facial nerve was not damaged during the procedure and the surgeon did not resort back to the standard implantation method. We will measure the percentage of participants who underwent successful cochlear implantation via the percutaneous method.
Results and safety
The study was stopped early (reason given: Currently in the process of submitting IDE to the FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Click here for more information related to Dr. Labadie and Otology Research at Vanderbilt University Medical CenterLink provided by the sponsor.
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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.
Robert F. Labadie, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Cochlear Implantation using image guided surgical techniques in people with Hearing Loss, run by Vanderbilt University 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Dec 2014. 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?
The study was stopped early (reason given: Currently in the process of submitting IDE to the FDA). Results are not available in the source record.
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?
Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method (time frame: Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.). 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 16 Dec 2014.