Appendix, UltrasonographyTIATNCT02665767
Telementoring for Identifying the Appendix Using Telesonography
A study testing Smartphone-based Telesonography in people with Appendix, Ultrasonography, run by Hanyang University at 1 site in South Korea.
Trial summary
The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendix, Ultrasonography
- What is being tested?
- Smartphone-based Telesonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Oct 2015
- 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Without any experience in ultrasonography
Who cannot join
- Subjects who do not want to participate
- Subjects who has eye pain or any eye problem
- Subjects who has wrist pain
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
About this study
Official title: A Feasibility Study of Telementoring for Identifying the Appendix Using Smartphone-based Telesonography
The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix.
Read the detailed description
A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.
Each subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix.
- Conditions
- Appendix, Ultrasonography
- Being tested
- Smartphone-based Telesonography
- Keywords
- Telesonography, Appendix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based TelesonographyDevice
The 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.
| Study group | Role | What they receive |
|---|---|---|
| On-site sonography | No intervention | The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert. |
| Smartphone-based Telesonography | Active comparator | The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert. Receives: Device: Smartphone-based Telesonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
"Success" is meaning of identifying appendix in 10 minutes.
Measured: 8 months
Secondary outcomes (1)
Time to identifying appendix
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendix, UltrasonographyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YOON-JE, Hanyang University
- Investigators
- YOONJE LEE, M.D., Principal investigator, Departement of Emergency Medicine, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665767
- Sponsor's protocol ID
- Hanyang University
- Acronym
- TIAT
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Telementoring for Identifying the Appendix Using Smartphone-based Telesonography
- ClinicalTrials.gov ID
- NCT02665767
- Acronym / sponsor ID
- TIAT / Hanyang University
- Conditions
- Appendix, Ultrasonography
- Keywords
- Telesonography, Appendix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Jan 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.
The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix.
Detailed description
A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.
Each subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-site sonography | No intervention | –The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert. |
| Smartphone-based Telesonography | Active comparator | Device: Smartphone-based TelesonographyThe subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Without any experience in ultrasonography
Key exclusion criteria (3 listed)
- Subjects who do not want to participate
- Subjects who has eye pain or any eye problem
- Subjects who has wrist pain
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 |
|---|---|---|
| Smartphone-based TelesonographyThe 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase. | Device | Smartphone-based Telesonography |
Primary outcome
Success rate
Time frame: 8 months
"Success" is meaning of identifying appendix in 10 minutes.
1 secondary outcome
Time to identifying appendix
Time frame: 8 months
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 28 Jan 2016.
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.
YOONJE LEE, M.D. principal investigator
Departement of Emergency Medicine, Hanyang University Guri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based Telesonography in people with Appendix, Ultrasonography, run by Hanyang University at 1 site in South Korea.
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 3 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 28 Jan 2016. 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 South Korea. 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?
Success rate (time frame: 8 months). 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 28 Jan 2016; AzTrials last refreshed its copy on 28 Oct 2026.