Recruiting

Robotic Telesonography

Sponsor:

University of Saskatchewan

Code:

NCT02607475

Conditions

Adult Abdominal Imaging

Pediatric Abdominal Imaging

Obstetric Imaging

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

Robotic telesonography (MELODY Patient System, AdEchoTech)

Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)

Study Details

Brief 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 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.

Conditions

Adult Abdominal Imaging

Pediatric Abdominal Imaging

Obstetric Imaging

Study ID

NCT02607475

Start date

Nov, 2015

Status verified date

Sep, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria above
  • Patients who are in distress prior to or during the exam

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Robotic telesonography compared to conventional sonography

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).

Interventions

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).

Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)

Conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare) ultrasound systems.

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 ]

Central Contacts and Locations

Central contacts

Scott J. Adams

306-373-7198scott.adams@usask.ca

Locations

Saskatoon Medical Imaging

Recruiting

Saskatoon, Saskatchewan, Canada, S7K 0W2

Contacts

Brent Burbridge, MD, FRCPC

306-655-2410brent.burbridge@usask.ca

Principal Investigator:

Paul Babyn, MD, FRCPC

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Paul S. Babyn, MDCM, FRCPC

306-655-2379paul.babyn@saskatoonhealthregion.ca

Principal Investigator:

Paul Babyn, MDCM, FRCPC

The Ultrasound Centre

Recruiting

Saskatoon, Saskatchewan, Canada

More Information

Sponsor

University of Saskatchewan

Last update posted

Oct 7, 2021

Last verified

Sep, 2021

Keywords

  • telesonography
  • ultrasound
  • robotic telesonography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2021-10-07.