Middle Ear InfectionNCT01485471
Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)
An observational study of Middle Ear Infection, run by University of California, Irvine.
Trial summary
Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Middle Ear Infection
- What is being tested?
- Diffuse optical spectroscopy imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: UCI otolaryngology clinic
Who may be able to join
- Male/ female at all age- newborn to adult.
- Non- pregnant woman.
- Diagnose of middle ear infection and plan for surgery procedure.
Who cannot join
- Pregnant woman
- Incompetent adults (i.e. individuals with cognitive impairment)
- No diagnose of middle ear infection and no plan for surgery procedure.
- Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
About this study
Official title: Spectroscopic Evaluation of Middle Ear Infection
Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.
Read the detailed description
The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.
Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states
- Conditions
- Middle Ear Infection
- Being tested
- Diffuse optical spectroscopy imaging
- Keywords
- Middle Ear Infection
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse optical spectroscopy imagingDevice
ear exam imaging
| Study group | Role | What they receive |
|---|---|---|
| Medical Tool | Diffuse optical spectroscopy imaging ear exam Receives: Device: Diffuse optical spectroscopy imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle Ear exam
Diffuse optical spectroscopy imaging to evaluate ear drum
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: No paticipants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Elliot Botvinick, Ph.D, Principal investigator, Beckman Laser InstituteBruce Tromberg, PhD, Study director, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485471
- Sponsor's protocol ID
- 20108015
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2011
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic Evaluation of Middle Ear Infection
- ClinicalTrials.gov ID
- NCT01485471
- Acronym / sponsor ID
- 20108015
- Conditions
- Middle Ear Infection
- Keywords
- Middle Ear Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No paticipants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Dec 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.
Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.
Detailed description
The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.
Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Tool | – | Device: Diffuse optical spectroscopy imagingDiffuse optical spectroscopy imaging ear exam |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- UCI otolaryngology clinic
Key inclusion criteria (3 listed)
- Male/ female at all age- newborn to adult.
- Non- pregnant woman.
- Diagnose of middle ear infection and plan for surgery procedure.
Key exclusion criteria (4 listed)
- Pregnant woman
- Incompetent adults (i.e. individuals with cognitive impairment)
- No diagnose of middle ear infection and no plan for surgery procedure.
- Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
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 |
|---|---|---|
| Diffuse optical spectroscopy imagingear exam imaging | Device | Medical Tool |
Primary outcome
Middle Ear exam
Time frame: 6 hours
Diffuse optical spectroscopy imaging to evaluate ear drum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
Elliot Botvinick, Ph.D principal investigator
Beckman Laser Institute
Bruce Tromberg, PhD study director
Beckman Laser Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Middle Ear Infection, run by University of California, Irvine.
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 3 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Middle Ear exam (time frame: 6 hours). 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 1 Nov 2022.