TelemedicineTelemedicineNCT02108717
The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone
A study testing Remote CT reading using the iPhone and CT reading using LCD monitor in people with Telemedicine, run by Hanyang University at 1 site in South Korea.
Trial summary
1. Purpose The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination. 2. Read more about this study
- Who is it for?
- Ages 33 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Remote CT reading using the iPhone and CT reading using LCD monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to May 2014
- 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 33 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Board certified emergency physicians with a clinical experience of 5 years and over.
Who cannot join
- Corrected eyesight < 20/30
- Color weakness or blindness
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang university guri hospital, Department of emergency medicine
Guri-si, GyeongGido, 471-701
About this study
Official title: The Feasibility Study for Remote CT Reading for Suspected Acute Appendicitis Using iPhone With Remote Control System in Realtime Under the Ambient Bright.
- Purpose
- The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination.
Read more
- Methods
- A total of 120 abdominal CT examinations; sixty had no findings of appendicitis, while the other sixty showed signs of acute appendicitis, were selected. The 16 raters reviewed these images using an LCD monitor of the PACS workstation and also an iPhone which was connected to the PACS workstation via remote control system, grading the probability of presence of acute appendicitis on each examination by a five Likert scale.
- The investigators will compare the diagnostic performance between two devices.
Read the detailed description
The 16 raters were randomly divided into two groups
- The raters in group one reviewed the CT examinations numbered from one to 60 using LCD monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit
- The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.
- They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
- The raters were instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).
- Conditions
- Telemedicine
- Being tested
- Remote CT reading using the iPhone, CT reading using LCD monitor
- Keywords
- Telemedicine, appendicitis, remote consultation
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote CT reading using the iPhoneDevice
Also called Smartphone (A1530, iPhone 5S, USA)
CT reading using LCD monitorDevice
Also called LCD monitor (MX210, EIZO, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit.
They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session. Receives: Device: Remote CT reading using the iPhone; Device: CT reading using LCD monitor |
| Group II | Experimental | The raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.
They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session. Receives: Device: Remote CT reading using the iPhone; Device: CT reading using LCD monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance between iPhone and LCD monitor
- Dorfman-Berbaum-Metz method with RSCORE and semi-parametric estimation of ROC indices by using the DMB-MRMC software (version 2.3, available at http://perception.radiology.uiowa.edu)
- 95% confidence interval
- The reviewers and cases are taken as random factors
Measured: within one day
Diagnostic accuracy between the iPhone and the LCD monitor
◆ Sensitivity, specificity
- gold standard: The pathology report and the results of clinical follow up
- grade 1, 2 and 3 = negative appendicitis findings
- grade 4 and 5 = positive appendicitis findings
- McNemar's test to compare the sensitivity and specificity between the iPhad and the LCD monitor
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changsun Kim, Hanyang University
- Investigators
- Bo Seung Kang, MD, Study director, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108717
- Sponsor's protocol ID
- 2014-02
- Acronym
- Telemedicine
- Status last verified
- May 2014
- First submitted
- 7 Apr 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8.
PubMed 22067287Choudhri AF, Carr TM 3rd, Ho CP, Stone JR, Gay SB, Lambert DL. Handheld device review of abdominal CT for the evaluation of acute appendicitis. J Digit Imaging. 2012 Aug;25(4):492-6. doi: 10.1007/s10278-011-9431-9.
PubMed 22146833Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0.
PubMed 23404630Kim C, Kang B, Choi HJ, Park JB. A Feasibility Study of Real-Time Remote CT Reading for Suspected Acute Appendicitis Using an iPhone. J Digit Imaging. 2015 Aug;28(4):399-406. doi: 10.1007/s10278-015-9775-7.
PubMed 25700617
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Study for Remote CT Reading for Suspected Acute Appendicitis Using iPhone With Remote Control System in Realtime Under the Ambient Bright.
- ClinicalTrials.gov ID
- NCT02108717
- Acronym / sponsor ID
- Telemedicine / 2014-02
- Conditions
- Telemedicine
- Keywords
- Telemedicine, appendicitis, remote consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Apr 2014 (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.
- Purpose
- The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination.
- Methods
- A total of 120 abdominal CT examinations; sixty had no findings of appendicitis, while the other sixty showed signs of acute appendicitis, were selected. The 16 raters reviewed these images using an LCD monitor of the PACS workstation and also an iPhone which was connected to the PACS workstation via remote control system, grading the probability of presence of acute appendicitis on each examination by a five Likert scale.
- The investigators will compare the diagnostic performance between two devices.
Detailed description
The 16 raters were randomly divided into two groups
- The raters in group one reviewed the CT examinations numbered from one to 60 using LCD monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit
- The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.
- They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
- The raters were instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: Remote CT reading using the iPhone, Device: CT reading using LCD monitorThe raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session. |
| Group II | Experimental | Device: Remote CT reading using the iPhone, Device: CT reading using LCD monitorThe raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session. |
Who may qualify
- Ages
- 33 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Board certified emergency physicians with a clinical experience of 5 years and over.
Key exclusion criteria (2 listed)
- Corrected eyesight < 20/30
- Color weakness or blindness
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 |
|---|---|---|
| Remote CT reading using the iPhoneAlso: Smartphone (A1530, iPhone 5S, USA) | Device | Group I, Group II |
| CT reading using LCD monitorAlso: LCD monitor (MX210, EIZO, Japan) | Device | Group I, Group II |
Primary outcome
Diagnostic performance between iPhone and LCD monitor
Time frame: within one day
* Dorfman-Berbaum-Metz method with RSCORE and semi-parametric estimation of ROC indices by using the DMB-MRMC software (version 2.3, available at http://perception.radiology.uiowa.edu) * 95% confidence interval * The reviewers and cases are taken as random factors
Diagnostic accuracy between the iPhone and the LCD monitor
Time frame: within one day
◆ Sensitivity, specificity * gold standard: The pathology report and the results of clinical follow up * grade 1, 2 and 3 = negative appendicitis findings * grade 4 and 5 = positive appendicitis findings * McNemar's test to compare the sensitivity and specificity between the iPhad and the LCD monitor
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 8 May 2014.
- Background: PubMed 22067287Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8.
- Background: PubMed 22146833Choudhri AF, Carr TM 3rd, Ho CP, Stone JR, Gay SB, Lambert DL. Handheld device review of abdominal CT for the evaluation of acute appendicitis. J Digit Imaging. 2012 Aug;25(4):492-6. doi: 10.1007/s10278-011-9431-9.
- Background: PubMed 23404630Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0.
- Derived from this study: PubMed 25700617Kim C, Kang B, Choi HJ, Park JB. A Feasibility Study of Real-Time Remote CT Reading for Suspected Acute Appendicitis Using an iPhone. J Digit Imaging. 2015 Aug;28(4):399-406. doi: 10.1007/s10278-015-9775-7.
- Displaymate: Flagship Smartphone Display Technology Shoot-OutLink provided by the sponsor.
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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.
Bo Seung Kang, MD study director
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 Remote CT reading using the iPhone and CT reading using LCD monitor in people with Telemedicine, 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 2 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 8 May 2014. 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?
Diagnostic performance between iPhone and LCD monitor (time frame: within one 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?
On the ClinicalTrials.gov record for NCT02108717, which also lists 4 linked publications.
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 8 May 2014.