Ultrasound Therapy; ComplicationsNCT05031884
Vision-based Ultrasonic Robot Autonomous Scanning Research
An observational study of Ultrasound Therapy; Complications, run by Rongqin Zheng at 1 site in China.
Trial summary
MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- MGIR3-US
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2021to 31 Aug 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers are encouraged in the study.
Who may be able to join
- patients who agree using MGIR3 to do ultrasonic examinations
- age from 18 to 65
Who cannot join
- Patients who has trauma on the inspection site or on the body surface
- Pregnant patients.
- Patients who are afraid of MGIR3-US
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510680
Jie Ren, Dr., 13560357934, luxue2@mail2.sysu.edu.cn
About this study
MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- MGIR3-US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGIR3-USDevice
MGIR3-US is an remote scanning robot which can do ultrasonic examinations.
| Study group | Role | What they receive |
|---|---|---|
| MGIR3-US group | using MGIR3-US to do ultrasonic examinations. Receives: Device: MGIR3-US | |
| control group | using conventional B-mode ultrasound to do ultrasonic examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of satisfaction in participants
The degree of satisfaction in participants
Measured: from 2021.08 to 2024.08
Secondary outcomes (2)
The degree of satisfaction in doctors
The degree of satisfaction in doctors
Measured: from 2021.08 to 2024.08
the lesion inspection rate
the lesion inspection rate
Measured: from 2021.08 to 2024.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start31 Aug 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rongqin Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jie Ren, doctor, Principal investigator, the third affiated hosptial of Sun Yat-sun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031884
- Sponsor's protocol ID
- sysu-robot 2021
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision-based Ultrasonic Robot Autonomous Scanning Research
- ClinicalTrials.gov ID
- NCT05031884
- Acronym / sponsor ID
- sysu-robot 2021
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Rongqin ZhengUniversity, hospital or other
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Sep 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.
MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGIR3-US group | – | Device: MGIR3-USusing MGIR3-US to do ultrasonic examinations. |
| control group | – | –using conventional B-mode ultrasound to do ultrasonic examinations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers are encouraged in the study.
Key inclusion criteria (2 listed)
- patients who agree using MGIR3 to do ultrasonic examinations
- age from 18 to 65
Key exclusion criteria (3 listed)
- Patients who has trauma on the inspection site or on the body surface
- Pregnant patients.
- Patients who are afraid of MGIR3-US
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGIR3-USMGIR3-US is an remote scanning robot which can do ultrasonic examinations. | Device | MGIR3-US group |
Primary outcome
The degree of satisfaction in participants
Time frame: from 2021.08 to 2024.08
The degree of satisfaction in participants
2 secondary outcomes
The degree of satisfaction in doctors
Time frame: from 2021.08 to 2024.08
the lesion inspection rate
Time frame: from 2021.08 to 2024.08
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jie Ren, doctor principal investigator
the third affiated hosptial of Sun Yat-sun University
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 Ultrasound Therapy; Complications, run by Rongqin Zheng at 1 site in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Sep 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Lu, doctor (13560357934, luxue2@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of satisfaction in participants (time frame: from 2021.08 to 2024.08). 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 2 Sep 2021.