Assessment of the Echoendoscope for Clinical Performance

March 3, 2022 updated by: Tao Guo, Peking Union Medical College Hospital

Prospective Comparison of Two EUS System for Clinical Performance

The primary objective for this study is to compare the safety and validity of two endoscopic ultrasonography (EUS) systems (GF-UE260-ME2 and EG-UR5-S50) used for clinical performance and establish a relative EUS performance assessment system and clinical case data to provide support for the product performance improvement.

Study Overview

Status

Completed

Conditions

Detailed Description

This research is a random, opening and parallel-controlled clinical test. Tested device model: The EG-UR5 ultrasonic endoscope manufactured by SonoSscope Medical Crop. That used with the HD-500 image processor, HDL-500X light source and S50Exp ultrasonic color doppler instrument .

Compared device model: The GF-UE260-ME2 ultrasonic endoscope manufactured by Olympus and its compatible light source, image processor and ultrasonic instrument.

To scientifically compare the clinical performances of the test model and the compared model, the enrolled objects would be randomly distributed to the tested group and the compared group to conducted the examination with the tested model and the compared model respectively.

EUS will be performed in the standard fashion by one of the experienced endosonographers in the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.

  1. Check Points Providing optical images of the human upper gestrointesinal tract (including esophagus, stomach and duodenum) for observing, diagnosis and treatment, and for the ultrasonic check and diagnosis for the upper gastrointestinal tract and surrounding organs.
  2. Test Items 1. Ultrasonic and endoscopic image quality assessment 2. Device controllability assessment 3. System safety assessment 4. System stability assessment

The data are recorded in the CRF, including patient information, clinical assessment for the usage of the endoscope and device operation, thus to perform a comprehensive assessment whether the safety and validity of this product can meet the clinical requirements.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Department of Gastroenterology, Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.

Description

Inclusion Criteria:

  1. The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
  2. Patients volunteering to participate in this study and sign the informed consent.

Exclusion Criteria:

  1. Patients do not sign the informed consent.
  2. Mental disorders and non-cooperated patient
  3. Severe cardiopulmonary diseases (such as severe cardiac dysfunction, severe pulmonary dysfunction and severe arrhythmia)
  4. Shock or other severe patient
  5. Suspected or confirmed upper digestive tract perforation or perforation acute phase
  6. Acute phase of gastric and esophageal chemical burns
  7. Patients do not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tested device model (EG-UR5-S50 )
Tested device model: The EG-UR5 echoendoscope manufactured by SonoSscope Medical Crop. That used with the HD-500 image processor, HDL-500X light source and S50 ultrasonic processor.
  1. Ultrasonic and endoscopic image quality assessment
  2. Device controllability assessment
  3. System safety assessment
  4. System stability assessment
Compared device model (GF-UE260-ME2)
Compared device model: The GF-UE260 echoendoscope manufactured by Olympus and its compatible light source, image processor and ME2 ultrasonic processor.
  1. Ultrasonic and endoscopic image quality assessment
  2. Device controllability assessment
  3. System safety assessment
  4. System stability assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonic Image Quality Assessment
Time Frame: up to 2 months

Check Points for Ultrasonic Image Esophagus, stomach, cholecyst, bile duct, pancreas and portal vein system Ultrasonic image quality Assessment standards Assess the ultrasonic image quality of all judgment points according to the ranking degree: excellent, well, bad. Only the assessment of all organs are excellent, the ultrasonic image quality is excellent. If one or more than one assessments are good, the ultrasonic image quality is good. If one or more than one assessments are bad, the ultrasonic image quality is bad.

The comparison of the image qualities of the tested model and compared model is verified by the non-inferior validation method and the boundary is 10%, and the confidence interval rate differential is 95%.

up to 2 months
Endoscopic Image Quality Assessment
Time Frame: up to 2 months

Check Points for endoscopic Image Esophagus, proximal stomach, stomach body,gastric angle,antrum and duodenal bulb.

Assess the ultrasonic image quality of all judgment points according to the ranking degree: excellent, well, bad. Only the assessment of all observed points are excellent, the endoscopic image quality is excellent. If one or more than one observation points are good, the endoscopic image quality is good. If one or more than one observation points are bad, the endoscopic image quality is bad.

The comparison of the image qualities of the tested model and compared model is verified by the non-inferior validation method and the boundary is 10%, and the confidence interval rate differential is 95%.

up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device controllability Assessment
Time Frame: up to 2 months
The good ration of the device controllability is computed to assess the performance of the ultrasonic endoscope and the target value is more than 98%.
up to 2 months
System safety assessment
Time Frame: up to 2 months
Judge the device safety according to the system safety adverse events and the target rate (the estimate value) of the events is 0.
up to 2 months
System stability assessment
Time Frame: up to 2 months
Judge the device stability according to the system stability adverse events and the target rate (the estimate value) of the events is less than 5%.
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tao Guo, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

February 22, 2022

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2017YFC0109804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data are private.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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