Abdominal Ultrasound ScanningNCT04999475
Evaluation of the Effectiveness of Robotic Assisted Ultrasonography System (ROBUST) in the Clinical Environment.
An observational study of Abdominal Ultrasound Scanning, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Abdominal Ultrasound Scanning
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2019to 23 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Adult, Older adult
Study population: Inpatients and Outpatients of Singapore General Hospital undergoing abdominal ultrasound scanning.
Who may be able to join
- Sonographer:
- -Experienced sonographers/ radiographers with more than 5 years of experience
- Patient:
- BMI <30
- Abdominal circumference <102cm
- Independent Ambulation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Abdominal Ultrasound Scanning
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Quality / Grading of ultrasound image for manual scanning and robot scanning
Measured: through recruitment completion, an average of 3 months
Comparing comfort level from sonographers for manual scanning and robot scanning
Measured: through recruitment completion, an average of 1 month
Comparing satisfaction level of patients for manual scanning and robot scanning
Measured: after scanning completion, after 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Jun 2019
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Ultrasound ScanningStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sengkang General Hospital, Servo Dynamics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999475
- Sponsor's protocol ID
- 2019/2491
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Robotic Assisted Ultrasonography System (ROBUST) in the Clinical Environment.
- ClinicalTrials.gov ID
- NCT04999475
- Acronym / sponsor ID
- 2019/2491
- Conditions
- Abdominal Ultrasound Scanning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Sengkang General Hospital, Servo Dynamics
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 80 years
- Age groups
- Adult, Older adult
- Study population
- Inpatients and Outpatients of Singapore General Hospital undergoing abdominal ultrasound scanning.
Key inclusion criteria (6 listed)
- -Experienced sonographers/ radiographers with more than 5 years of experience
- BMI <30
- Abdominal circumference <102cm
- Independent Ambulation
Key exclusion criteria (6 listed)
- -With previously reported work-related or non-work related musculoskeletal discomfort or injury
- Pregnancy
- Non-compliance/difficulty in adhering to instructions (e.g. control breathing)
- No known muscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing Quality / Grading of ultrasound image for manual scanning and robot scanning
Time frame: through recruitment completion, an average of 3 months
Comparing comfort level from sonographers for manual scanning and robot scanning
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Ultrasound Scanning, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Quality / Grading of ultrasound image for manual scanning and robot scanning (time frame: through recruitment completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.