Vision-based Ultrasonic Robot Autonomous Scanning Research | NCT05031884

Studies
Vision-based Ultrasonic Robot Autonomous Scanning Research

NCT05031884

Sponsor

Rongqin Zheng

Status

Not yet recruiting

Last Update Posted

Sep 2, 2021Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Ultrasound Therapy; Complications

Interventions

MGIR3-US

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2021Estimated

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Aug 29, 2021

First Submission Date that Met QC Criteria

Sep 1, 2021

First Posted Date

Sep 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MGIR3-US group		using MGIR3-US to do ultrasonic examinations.	Device: MGIR3-US
control group		using conventional B-mode ultrasound to do ultrasonic examinations.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MGIR3-US	Device	MGIR3-US is an remote scanning robot which can do ultrasonic examinations.	MGIR3-US group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of satisfaction in participants	The degree of satisfaction in participants	from 2021.08 to 2024.08

Secondary Outcomes

Measure	Description	Time Frame
The degree of satisfaction in doctors	The degree of satisfaction in doctors	from 2021.08 to 2024.08
the lesion inspection rate	the lesion inspection rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who agree using MGIR3 to do ultrasonic examinations
age from 18 to 65

Exclusion Criteria:

Patients who has trauma on the inspection site or on the body surface
Pregnant patients.
Patients who are afraid of MGIR3-US

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Volunteers are encouraged in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xue Lu, doctor	Contact	13560357934		luxue2@mail2.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Jie Ren, doctor	the third affiated hosptial of Sun Yat-sun University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Third Affiliated Hospital of Sun Yat-Sen University		Guangzhou	Guangdong	510680	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided