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NCT04999475

Evaluation of the Effectiveness of Robotic Assisted Ultrasonography System (ROBUST) in the Clinical Environment.

Completed Last updated 10 August 2021
What this trial tests

trial in Abdominal Ultrasound Scanning in 50 participants. Completed in 23 July 2020.

Timeline
1 June 2019
Primary endpoint
23 July 2020
23 July 2020

Quick facts

Lead sponsorSingapore General Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date1 June 2019
Primary completion23 July 2020
Estimated completion23 July 2020
Sites1 location across Singapore

Conditions studied

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 80, any sex, with Abdominal Ultrasound Scanning. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Work-related musculoskeletal disorders (WRMSD) among sonographers/radiographers are prevalent in the healthcare industry. This study will evaluate the use of a robotic assisted ultrasonography system (ROBUST) against the conventional abdominal ultrasound scanning procedure. The ROBUST will be developed to provide 6 degrees of freedom to allow radiographers to perform abdominal scanning without having to reach over patients. 6 sonographers with at least 5 years of experience will be recruited from SGH and SKH, to perform abdominal ultrasound scans on 50 patients. Patients will be screened by the radiographers in the study team for their suitability in the participation during their scheduled appointments and will be invited to undergo scanning with the ROBUST upon agreement. Outcome measures will include ultrasound image quality, sonographer feedback and comfort level as well as satisfaction feedback from patients. A panel of 4 reviewers, consisting of 2 radiologists and 2 senior radiographers will be invited to grade the images, using a 3-point Likert scale to compare the images taken with ROBUST against the images taken conventionally prior to using the ROBUST. The duration of each session will be recorded. The comfort level reported by sonographers will be assessed using the SGH Comfort Level Survey. In addition, the comfort level of participating patients will also be assessed using a satisfaction questionnaire. The investigators hypothesize that there is no difference in imaging quality and comfort levels of sonographers and patients between a conventional ultrasound scan and scanning with the ROBUST. The investigators also hypothesize that there would be a reduction in the risk of WRMSD among sonographers with reduction in ergonomic risk factors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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