PharyngitisNCT02723890
The Efficacy and Safety of Using the Novel Tyto Device
A study testing Tyto Device in people with Pharyngitis and Respiratory Diseases, run by Rabin Medical Center at 1 site in Israel.
Trial summary
To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pharyngitis, Respiratory Diseases, Cardiac Diseases
- What is being tested?
- Tyto Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Apr 2018
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage \& Acuity Scale (CTAS) scoring scale.
Who cannot join
- CTAS 1.
- Pregnant adolescent.
- Multi-drug resistant carriers.
- Intellectual disability disorders.
- Unsigned informed consent.
- Patients with CTAS score of 2-3, will be first addressed by a physician to ascertain their eligibility to be enrolled to the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
About this study
Official title: The Efficacy and Safety of Using the Novel Tyto Device for Remote Physical Examination by a Physician as Compared to a Standard Medical Physical Examination
To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.
Read the detailed description
A single center, prospective, qualitative study. Patients referred to the emergency department will be triaged according to The Canadian Triage \& Acuity Scale (CTAS).
Patients presenting with complaints suitable for examination with the Tyto device (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be informed and asked for consent. Patients participating in the study will be referred to a room dedicated for the purpose.
A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary Pilot Study. Final study design and its extent will be determined accordingly.
Physical examinations using the Tyto device will be performed by the co-investigators, and sent online to the principle investigator for remote analysis.
The emergency department physician will examine the patient using conventional examination instruments (i.e. stethoscope, otoscope).
The data collected will be recorded on predetermined case report form (CRF), timed, stored and analyzed by the principle and co-investigators. The findings of the co-investigators' examination will be compared to the conventional examination instruments used by the emergency department physician.
Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological findings)
- Conditions
- Pharyngitis, Respiratory Diseases, Cardiac Diseases, Ear Infection
- Being tested
- Tyto Device
- Medical subject headings
- Pharyngitis, Respiratory Tract Diseases, Heart Diseases, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyto DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Tyto Device | Experimental | examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis. Receives: Device: Tyto Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance of diagnosis and physical findings using the Tyto device on the heart, lung ear and throat as compared to standard physical examination (normal heart and lung sounds, arrhythmia, crackles, normal appearance of ear and throat or otherwise)
during the visit to the emergency department.
Measured: up to 6 hrs
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
during the visit to the emergency department.
Measured: up to 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waisman yehezkel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723890
- Sponsor's protocol ID
- RMC-15-0266
- Status last verified
- Apr 2018
- First submitted
- 1 Mar 2016
- Last updated
- 24 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Using the Novel Tyto Device for Remote Physical Examination by a Physician as Compared to a Standard Medical Physical Examination
- ClinicalTrials.gov ID
- NCT02723890
- Acronym / sponsor ID
- RMC-15-0266
- Conditions
- Pharyngitis, Respiratory Diseases, Cardiac Diseases, Ear Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 31 Mar 2016 (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.
To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.
Detailed description
A single center, prospective, qualitative study. Patients referred to the emergency department will be triaged according to The Canadian Triage \& Acuity Scale (CTAS).
Patients presenting with complaints suitable for examination with the Tyto device (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be informed and asked for consent. Patients participating in the study will be referred to a room dedicated for the purpose.
A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary Pilot Study. Final study design and its extent will be determined accordingly.
Physical examinations using the Tyto device will be performed by the co-investigators, and sent online to the principle investigator for remote analysis.
The emergency department physician will examine the patient using conventional examination instruments (i.e. stethoscope, otoscope).
The data collected will be recorded on predetermined case report form (CRF), timed, stored and analyzed by the principle and co-investigators. The findings of the co-investigators' examination will be compared to the conventional examination instruments used by the emergency department physician.
Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological findings)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tyto Device | Experimental | Device: Tyto Deviceexamination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage \& Acuity Scale (CTAS) scoring scale.
Key exclusion criteria (6 listed)
- CTAS 1.
- Pregnant adolescent.
- Multi-drug resistant carriers.
- Intellectual disability disorders.
- Unsigned informed consent.
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 |
|---|---|---|
| Tyto Device | Device | Tyto Device |
Primary outcome
The concordance of diagnosis and physical findings using the Tyto device on the heart, lung ear and throat as compared to standard physical examination (normal heart and lung sounds, arrhythmia, crackles, normal appearance of ear and throat or otherwise)
Time frame: up to 6 hrs
during the visit to the emergency department.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 6 hrs
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 24 Apr 2018.
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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 Tyto Device in people with Pharyngitis and Respiratory Diseases, run by Rabin Medical Center at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 24 Apr 2018. 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 Israel. 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?
The concordance of diagnosis and physical findings using the Tyto device on the heart, lung ear and throat as compared to standard physical examination (normal heart and lung sounds, arrhythmia, crackles, normal appearance of ear and throat or otherwise) (time frame: up to 6 hrs). 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 24 Apr 2018.