- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04999475
Evaluation of the Effectiveness of Robotic Assisted Ultrasonography System (ROBUST) in the Clinical Environment.
Study Overview
Status
Conditions
Detailed Description
6 participating sonographers will be recruited from SGH and SKH to perform abdominal ultrasound scanning. 50 patients of average body habitus with BMI <30, abdominal circumference <102cm, of whom are able to ambulate independently will be screened for suitability during their scheduled appointments and recruited. These patients from SGH and SKH, will be referred by their radiographers for the study and will be screened by the Study Team Radiographers to obtain consent. Suitable patients for the study are determined after the scheduled abdominal scans are performed at the clinic.
Patients will undergo scanning with participating sonographers using the ROBUST after completion of their scheduled conventional scans. The same ultrasound scanner and probe type will be used on all participating patients by all sonographers.
At the end of both scans, participating sonographers will be required to complete a survey on comfort level. At the end of both scans, patients will be required to complete a survey on satisfaction level. The quality of the images from both scans will be graded by 4 readers: 2 consultant radiologists and 2 senior radiographers. A photometer will be used to ensure all graders interpret the images directly from a designated monitor under consistent lighting condition.
In the first stage, ROBUST intends to scale up to expand across SingHealth institutions via a commercial partner. Together with the team, the company will engage key opinion leaders, key stakeholders and key users of respective healthcare institutions in Singapore. The team will work closely with the identified deployment partners to develop customised solutions to suit specific requirements based on disease and type of ultrasound services provided by the healthcare institutions. If successful, the ROBUST can be deployed in all ultrasound examination rooms to benefit larger population of ultrasound radiographers in managing manpower limitation and reducing work-related musculoskeletal risks. ROBUST is designed to be universal and can integrate with existing ultrasound probe, eliminating the need for a new capital purchase.
In the second stage, ROBUST will further be deployed to other national healthcare cluster within Singapore. To achieve stage 1 and stage 2 of deployment plan, the ROBUST project team will seek endorsement from key stakeholders of healthcare clusters, Group CEOs and Group COOs from NHG and NUHS at the national level to encourage technology adoption by the respective healthcare clusters.
Following success of stage 1 and stage 2, ROBUST will be marketed to key regions in Asia and Pacific countries especially ageing population nations like Japan, Hong Kong, South Korea, Australia and New Zealand through strategic distribution partners. In the third stage, based on a universal platform, ROBUST can be further expanded into the surgical domain to enable assistive solution to surgeons operating in long duration. Similarly, ROBUST can help to mitigate risk of musculoskeletal disorders among surgeons and doctors.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 169608
- Singapore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Sonographer:
-Experienced sonographers/ radiographers with more than 5 years of experience
Patient:
- BMI <30
- Abdominal circumference <102cm
- Independent Ambulation
Exclusion Criteria:
Sonographer:
-With previously reported work-related or non-work related musculoskeletal discomfort or injury
Patient:
- Pregnancy
- Non-compliance/difficulty in adhering to instructions (e.g. control breathing)
- No known muscular disorders
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparing Quality / Grading of ultrasound image for manual scanning and robot scanning
Time Frame: through recruitment completion, an average of 3 months
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through recruitment completion, an average of 3 months
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Comparing comfort level from sonographers for manual scanning and robot scanning
Time Frame: through recruitment completion, an average of 1 month
|
through recruitment completion, an average of 1 month
|
Comparing satisfaction level of patients for manual scanning and robot scanning
Time Frame: after scanning completion, after 40 minutes
|
after scanning completion, after 40 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019/2491
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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