Evaluation of Robotic Telesonography

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.

Study Overview

• Status: Recruiting
• Conditions: Adult Abdominal Imaging; Pediatric Abdominal Imaging; Obstetric Imaging
• Intervention / Treatment: Device: Robotic telesonography (MELODY Patient System, AdEchoTech); Device: Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott J. Adams; Phone Number: 306-373-7198; Email: scott.adams@usask.ca

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Royal University Hospital
      • Sub-Investigator: Brent Burbridge, MD, FRCPC
      • Sub-Investigator: Haron Obaid, MD, FRCPC
      • Sub-Investigator: Ivar Mendez, MD, PhD, FRCSC, FACS, FCAHS
      • Contact: Paul S. Babyn, MDCM, FRCPC; Phone Number: 306-655-2379; Email: paul.babyn@saskatoonhealthregion.ca
      • Principal Investigator: Paul Babyn, MDCM, FRCPC
    • Saskatoon, Saskatchewan, Canada, S7K 0W2
      • Recruiting
      • Saskatoon Medical Imaging
      • Contact: Brent Burbridge, MD, FRCPC; Phone Number: 306-655-2410; Email: brent.burbridge@usask.ca
      • Sub-Investigator: Brent Burbridge, MD, FRCPC
      • Sub-Investigator: Haron Obaid, MD, FRCPC
      • Sub-Investigator: Ivar Mendez, MD, PhD, FRCSC, FACS, FCAHS
      • Principal Investigator: Paul Babyn, MD, FRCPC
    • Saskatoon, Saskatchewan, Canada
      • Recruiting
      • The Ultrasound Centre
      • Sub-Investigator: Brent Burbridge, MD, FRCPC
      • Contact: Brent Burbridge, MD
      • Sub-Investigator: Paul Babyn, MDCM, FRCPC
      • Sub-Investigator: Ivar Mendez, MD, PhD, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Research images will be interpreted within 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of robotic telesonography exams relative to conventional sonography	1 day
Acceptability of the robotic telesonography experience to patients measured using Likert items	1 day
Acceptability of the robotic telesonography system to remote users (sonographers) and patient-site assistants measured using Likert items	1 day

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Paul S. Babyn, MDCM, FRCPC, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; telesonography; robotic telesonography
• Other Study ID Numbers: RT-01