Ear InfectionTMED_FOG_001NCT06781164
Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases
A study testing telemedicine in people with Ear Infection and Telemedicine, run by Szeged University at 1 site in Hungary.
Trial summary
System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis. Characteristics of the medical device: The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Ear Infection, Telemedicine
- What is being tested?
- telemedicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2020to 31 May 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent form
- Patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,)
- The subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance.
Who cannot join
- Poor general condition
- Based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: Liquor dripping, massive bleeding, etc.)
- Any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test
- The examiner finds that further participation is a disadvantage for the patient for any reason;
- the patient requests the suspension of his participation orally or in writing
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Otorhinolaryngology and Head and Neck Surgery Clinic
Szeged, Csongrád megye, 6720
About this study
System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis.
Characteristics of the medical device:
The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation.
Read the detailed description
The detailed operation is in the user guide in Hungarian included. The device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints).
The telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy.
The study is a prospective, single-arm study. The specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine The diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.
- Conditions
- Ear Infection, Telemedicine
- Being tested
- telemedicine
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicineDevice
Recording of the ear of each patient with an ear problem
| Study group | Role | What they receive |
|---|---|---|
| telemedicine arm | Experimental | A recording of the ear of each patient with an ear problem was taken with the device, and then they were diagnosed and prescribed therapy in the traditional way. Receives: Device: telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist.
The primary objectives of the study is: number of matching cases, measured with the similarity and matching of International Classification of Diseases (ICD) codes.
Measured: 1 day
Comparison of therapy
Matching or similarity of prescribed therapy, e.g. same family of antibiotics , or the type of active substance. The match based on Anatomical Therapeutic Chemical (ATC) Classification
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Apr 2020
- Primary completion23 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear InfectionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781164
- Sponsor's protocol ID
- University of Szeged
- Acronym
- TMED_FOG_001
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases
- ClinicalTrials.gov ID
- NCT06781164
- Acronym / sponsor ID
- TMED_FOG_001 / University of Szeged
- Conditions
- Ear Infection, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 17 Jan 2025 (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.
System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis.
Characteristics of the medical device:
The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation.
Detailed description
The detailed operation is in the user guide in Hungarian included. The device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints).
The telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy.
The study is a prospective, single-arm study. The specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine The diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telemedicine arm | Experimental | Device: telemedicineA recording of the ear of each patient with an ear problem was taken with the device, and then they were diagnosed and prescribed therapy in the traditional way. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent form
- Patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,)
- The subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance.
Key exclusion criteria (5 listed)
- Poor general condition
- Based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: Liquor dripping, massive bleeding, etc.)
- Any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test
- The examiner finds that further participation is a disadvantage for the patient for any reason;
- the patient requests the suspension of his participation orally or in writing
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 |
|---|---|---|
| telemedicineRecording of the ear of each patient with an ear problem | Device | telemedicine arm |
Primary outcome
Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist.
Time frame: 1 day
The primary objectives of the study is: number of matching cases, measured with the similarity and matching of International Classification of Diseases (ICD) codes.
Comparison of therapy
Time frame: 1 day
Matching or similarity of prescribed therapy, e.g. same family of antibiotics , or the type of active substance. The match based on Anatomical Therapeutic Chemical (ATC) Classification
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 17 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 telemedicine in people with Ear Infection and Telemedicine, run by Szeged University at 1 site in Hungary.
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 5 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 17 Jan 2025. 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 Hungary. 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?
Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist. (time frame: 1 day). The study lists 2 primary outcomes in all. 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 17 Jan 2025.