Otitis MediaNCT01611246
Earset Healthy Volunteer Study
An observational study of Otitis Media, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES). Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Otitis Media
- What is being tested?
- Iontophoresis System With Earset
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2012to 1 Aug 2012
- Phase
- Observational
- 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 12 months old
Who cannot join
- Pregnant or lactating females
- Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
- Significantly atrophic or perforated tympanic membrane
- Otitis externa
- Damaged or denuded skin in the auditory canal
- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- 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 of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
- Conditions
- Otitis Media
- Being tested
- Iontophoresis System With Earset
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis System With EarsetDevice
iontophoresis of lidocaine-based solution for numbing tympanic membrane
| Study group | Role | What they receive |
|---|---|---|
| Anesthetization | Anesthetization Receives: Device: Iontophoresis System With Earset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects anesthetized as assessed by Wong-Baker scale
Measured: Day 1
Secondary outcomes (1)
Number of participants with serious adverse events
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study start1 May 2012
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies 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
- Observational
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Joseph Roberson, M.D., Principal investigator, CEI Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611246
- Sponsor's protocol ID
- CPR005031
- Status last verified
- Jul 2024
- First submitted
- 29 May 2012
- 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 of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01611246
- Acronym / sponsor ID
- CPR005031
- Conditions
- Otitis Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 4 Jun 2012 (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 recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthetization | – | Device: Iontophoresis System With EarsetAnesthetization |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least 12 months old
Key exclusion criteria (8 listed)
- Pregnant or lactating females
- Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
- Significantly atrophic or perforated tympanic membrane
- Otitis externa
- Damaged or denuded skin in the auditory canal
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 |
|---|---|---|
| Iontophoresis System With Earsetiontophoresis of lidocaine-based solution for numbing tympanic membrane | Device | Anesthetization |
Primary outcome
Number of subjects anesthetized as assessed by Wong-Baker scale
Time frame: Day 1
1 secondary outcome
Number of participants with serious adverse events
Time frame: Day 1
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.
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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.
Joseph Roberson, M.D. principal investigator
CEI Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, 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 1 inclusion and 8 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?
Number of subjects anesthetized as assessed by Wong-Baker scale (time frame: Day 1). 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.