Evaluate Performance and Reliability of Iontophoresis SystemNCT01047904
Anesthetizing the Tympanic Membrane in Healthy Volunteers
A study testing Acclarent Iontophoresis System in people with Evaluate Performance and Reliability of Iontophoresis System, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluate Performance and Reliability of Iontophoresis System
- What is being tested?
- Acclarent Iontophoresis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2009
- 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
- >=18 years of age
- Both male and female subjects are eligible.
Who cannot join
- Pregnant or lactating females
- Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
- Markedly atrophic TM
- Perforated TM
- Sclerotic TM
- Otitis externa
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- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- Damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.
- Being tested
- Acclarent Iontophoresis System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acclarent Iontophoresis SystemDevice
Administration of local anesthesia using the Acclarent Iontophoresis System
| Study group | Role | What they receive |
|---|---|---|
| Iontophoresis-treated | Experimental | Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM. Receives: Device: Acclarent Iontophoresis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers
Measured: X days
Secondary outcomes (2)
Incidence of adverse effects associated with the System and the Iontophoresis procedure
The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device.
Measured: X days
Tolerability of the iontophoresis system
Subject tolerability of the iontophoresis procedure will be assessed using a pain scale
Measured: X days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Performance and Reliability of Iontophoresis SystemStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047904
- Sponsor's protocol ID
- CPR005006
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2010
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01047904
- Acronym / sponsor ID
- CPR005006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Jan 2010 (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 study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iontophoresis-treated | Experimental | Device: Acclarent Iontophoresis SystemHealthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >=18 years of age
- Both male and female subjects are eligible.
Key exclusion criteria (10 listed)
- Pregnant or lactating females
- Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
- Markedly atrophic TM
- Perforated TM
- Sclerotic TM
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 |
|---|---|---|
| Acclarent Iontophoresis SystemAdministration of local anesthesia using the Acclarent Iontophoresis System | Device | Iontophoresis-treated |
Primary outcome
Procedural Success
Time frame: X days
Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers
2 secondary outcomes
Incidence of adverse effects associated with the System and the Iontophoresis procedure
Time frame: X days
Tolerability of the iontophoresis system
Time frame: X days
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 11 Jul 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acclarent Iontophoresis System in people with Evaluate Performance and Reliability of Iontophoresis System, run by Integra LifeSciences Corporation 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 10 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 11 Jul 2024. 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 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?
Procedural Success (time frame: X days). 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 11 Jul 2024.