Evaluation of Robotic Telesonography

NCT ID: NCT02607475

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2022-06-30

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.

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.

Conditions

Adult Abdominal Imaging; Pediatric Abdominal Imaging; Obstetric Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Robotic telesonography (MELODY Patient System, AdEchoTech)

Intervention Type: 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)

Intervention Type: DEVICE

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

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).

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Patients who are in distress prior to or during the exam

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Paul Babyn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul S. Babyn, MDCM, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Saskatoon Medical Imaging

Saskatoon, Saskatchewan, Canada

Site Status: RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status: RECRUITING

The Ultrasound Centre

Saskatoon, Saskatchewan, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Scott J. Adams

Role: CONTACT

scott.adams@usask.ca

306-373-7198

Facility Contacts

Brent Burbridge, MD, FRCPC

Role: primary

brent.burbridge@usask.ca

306-655-2410

Paul S. Babyn, MDCM, FRCPC

Role: primary

paul.babyn@saskatoonhealthregion.ca

306-655-2379

Brent Burbridge, MD

Role: primary

Other Identifiers

RT-01

Identifier Type: -

Identifier Source: org_study_id