Adult Abdominal ImagingNCT02607475
Evaluation of Robotic Telesonography
A study testing Robotic telesonography (MELODY Patient System, AdEchoTech) and Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare) in people with Adult Abdominal Imaging and Pediatric Abdominal Imaging, run by University of Saskatchewan at 3 sites in Canada.
Trial summary
Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to perform sonography at remote centres. Using a robotic system and an assistant with limited training at the remote site, an expert can manipulate an ultrasound probe and generate images in… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Abdominal Imaging, Pediatric Abdominal Imaging, Obstetric Imaging
- What is being tested?
- Robotic telesonography (MELODY Patient System, AdEchoTech) and Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2015to Jun 2022
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to have an abdominal study or second trimester ultrasound study at Royal University Hospital or Saskatoon Medical Imaging.
- Pediatric abdominal substudy: male and female patients 5 years of age or older and less than 18 years of age
- Adult abdominal substudy: male and female patients 18 years of age and older
- Obstetrics substudy: second trimester patients 18 years of age and older
Who cannot join
- Patients who do not meet the inclusion criteria above
- Patients who are in distress prior to or during the exam
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Saskatoon Medical Imaging
Saskatoon, Saskatchewan, S7K 0W2
Brent Burbridge, MD, FRCPC, 306-655-2410, brent.burbridge@usask.ca
Brent Burbridge, MD, FRCPC
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Paul S. Babyn, MDCM, FRCPC, 306-655-2379, paul.babyn@saskatoonhealthregion.ca
Brent Burbridge, MD, FRCPC
- Recruiting
The Ultrasound Centre
Saskatoon, Saskatchewan
Brent Burbridge, MD
Paul Babyn, MDCM, FRCPC
About this study
Official title: Evaluation of Robotic Telesonography for Obstetric and Adult and Pediatric Abdominal Imaging
Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to perform sonography at remote centres. Using a robotic system and an assistant with limited training at the remote site, an expert can manipulate an ultrasound probe and generate images in real-time via an Internet connection. This study aims to demonstrate the feasibility of robotic telesonography for obstetric and adult and pediatric abdominal imaging in a centre with established sonography services which will be used as a comparator to robotic telesonography.
Read the detailed description
Lack of trained sonographers in remote communities limits access to sonography for many patients. As a result, patients must travel or be transported to secondary and tertiary care centres, which often delays diagnosis and subsequent treatment, creates burdens for patients and their families, and increases healthcare costs. Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to provide sonography regardless of the availability of a skilled operator at the site. Studies primarily originating in Europe have demonstrated robotic telesonography in abdominal, pelvic, obstetric, and cardiologic applications in adults. However, the full potential of robotic telesonography across many imaging applications has yet to be explored, and robotic telesonography has not yet been trialed in Canada. This study aims to demonstrate the feasibility of robotic telesonography in a centre with established sonography services which will be used as a comparator to robotic telesonography. Approximately 30 patients will be recruited for each substudy (obstetric, adult abdominal, and pediatric abdominal). All patients will receive both conventional and robotic scans in a crossover design. The sonographer performing the scan will be asked to complete a data collection form which will collect information about duration of the exam and any challenges encountered. Following the completion of both scans, the patient-site assistant will provide a questionnaire to the patient (or for children, a parent/guardian of the patient) regarding his/her experience with the system. A physician will review images generated using either the robotic telesonography or conventional sonography systems and report findings on a standardized reporting form.
- Being tested
- Robotic telesonography (MELODY Patient System, AdEchoTech), Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)
- Keywords
- telesonography, ultrasound, robotic telesonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic telesonography (MELODY Patient System, AdEchoTech)Device
Robotic telesonography using the MELODY Patient System (AdEchoTech) in conjunction with the SonixTablet ultrasound system (BK Ultrasound, formerly Ultrasonix).
Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)Device
Conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare) ultrasound systems.
| Study group | Role | What they receive |
|---|---|---|
| Robotic telesonography compared to conventional sonography | Experimental | All participants will receive two imaging studies: (1) Robotic telesonography using the MELODY Patient System (AdEchoTech) in conjunction with the SonixTablet ultrasound system (BK Ultrasound, formerly Ultrasonix), and (2) conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare). Receives: Device: Robotic telesonography (MELODY Patient System, AdEchoTech); Device: Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of robotic telesonography, expressed as the concordance of measurements and concordance of findings visualized with robotic telesonography using conventional sonography as a reference standard.
Measured: Research images will be interpreted within 8 weeks
Secondary outcomes (3)
Duration of robotic telesonography exams relative to conventional sonography
Measured: 1 day
Acceptability of the robotic telesonography experience to patients measured using Likert items
Measured: 1 day
Acceptability of the robotic telesonography system to remote users (sonographers) and patient-site assistants measured using Likert items
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 posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Abdominal ImagingStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Babyn, University of Saskatchewan
- Investigators
- Paul S. Babyn, MDCM, FRCPC, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607475
- Sponsor's protocol ID
- RT-01
- Status last verified
- Sep 2021
- First submitted
- 10 Nov 2015
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Robotic Telesonography for Obstetric and Adult and Pediatric Abdominal Imaging
- ClinicalTrials.gov ID
- NCT02607475
- Acronym / sponsor ID
- RT-01
- Keywords
- telesonography, ultrasound, robotic telesonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Nov 2015 (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.
Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to perform sonography at remote centres. Using a robotic system and an assistant with limited training at the remote site, an expert can manipulate an ultrasound probe and generate images in real-time via an Internet connection. This study aims to demonstrate the feasibility of robotic telesonography for obstetric and adult and pediatric abdominal imaging in a centre with established sonography services which will be used as a comparator to robotic telesonography.
Detailed description
Lack of trained sonographers in remote communities limits access to sonography for many patients. As a result, patients must travel or be transported to secondary and tertiary care centres, which often delays diagnosis and subsequent treatment, creates burdens for patients and their families, and increases healthcare costs. Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to provide sonography regardless of the availability of a skilled operator at the site. Studies primarily originating in Europe have demonstrated robotic telesonography in abdominal, pelvic, obstetric, and cardiologic applications in adults. However, the full potential of robotic telesonography across many imaging applications has yet to be explored, and robotic telesonography has not yet been trialed in Canada. This study aims to demonstrate the feasibility of robotic telesonography in a centre with established sonography services which will be used as a comparator to robotic telesonography. Approximately 30 patients will be recruited for each substudy (obstetric, adult abdominal, and pediatric abdominal). All patients will receive both conventional and robotic scans in a crossover design. The sonographer performing the scan will be asked to complete a data collection form which will collect information about duration of the exam and any challenges encountered. Following the completion of both scans, the patient-site assistant will provide a questionnaire to the patient (or for children, a parent/guardian of the patient) regarding his/her experience with the system. A physician will review images generated using either the robotic telesonography or conventional sonography systems and report findings on a standardized reporting form.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic telesonography compared to conventional sonography | Experimental | Device: Robotic telesonography (MELODY Patient System, AdEchoTech), Device: Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)All participants will receive two imaging studies: (1) Robotic telesonography using the MELODY Patient System (AdEchoTech) in conjunction with the SonixTablet ultrasound system (BK Ultrasound, formerly Ultrasonix), and (2) conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to have an abdominal study or second trimester ultrasound study at Royal University Hospital or Saskatoon Medical Imaging.
- Pediatric abdominal substudy: male and female patients 5 years of age or older and less than 18 years of age
- Adult abdominal substudy: male and female patients 18 years of age and older
- Obstetrics substudy: second trimester patients 18 years of age and older
Key exclusion criteria (2 listed)
- Patients who do not meet the inclusion criteria above
- Patients who are in distress prior to or during the exam
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 |
|---|---|---|
| Robotic telesonography (MELODY Patient System, AdEchoTech)Robotic telesonography using the MELODY Patient System (AdEchoTech) in conjunction with the SonixTablet ultrasound system (BK Ultrasound, formerly Ultrasonix). | Device | Robotic telesonography compared to conventional sonography |
| Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)Conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare) ultrasound systems. | Device | Robotic telesonography compared to conventional sonography |
Primary outcome
Diagnostic performance of robotic telesonography, expressed as the concordance of measurements and concordance of findings visualized with robotic telesonography using conventional sonography as a reference standard.
Time frame: Research images will be interpreted within 8 weeks
3 secondary outcomes
Duration of robotic telesonography exams relative to conventional sonography
Time frame: 1 day
Acceptability of the robotic telesonography experience to patients measured using Likert items
Time frame: 1 day
Acceptability of the robotic telesonography system to remote users (sonographers) and patient-site assistants measured using Likert items
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
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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.
Paul S. Babyn, MDCM, FRCPC principal investigator
University of Saskatchewan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic telesonography (MELODY Patient System, AdEchoTech) and Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare) in people with Adult Abdominal Imaging and Pediatric Abdominal Imaging, run by University of Saskatchewan at 3 sites in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott J. Adams (306-373-7198, scott.adams@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of robotic telesonography, expressed as the concordance of measurements and concordance of findings visualized with robotic telesonography using conventional sonography as a reference standard. (time frame: Research images will be interpreted within 8 weeks). 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 7 Oct 2021.