- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161950
Assessment of the Echoendoscope for Clinical Performance
Prospective Comparison of Two EUS System for Clinical Performance
Study Overview
Status
Conditions
Intervention / Treatment
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 Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.
- 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.
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Department of Gastroenterology, Peking Union Medical College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
- Patients volunteering to participate in this study and sign the informed consent.
Exclusion Criteria:
- Patients do not sign the informed consent.
- Mental disorders and non-cooperated patient
- Severe cardiopulmonary diseases (such as severe cardiac dysfunction, severe pulmonary dysfunction and severe arrhythmia)
- Shock or other severe patient
- Suspected or confirmed upper digestive tract perforation or perforation acute phase
- Acute phase of gastric and esophageal chemical burns
- Patients do not suitable to participate in this study.
Study Plan
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonic Image Quality Assessment
Time Frame: up to 2 months
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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
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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%.
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up to 2 months
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System safety assessment
Time Frame: up to 2 months
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Judge the device safety according to the system safety adverse events and the target rate (the estimate value) of the events is 0.
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up to 2 months
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System stability assessment
Time Frame: up to 2 months
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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%.
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up to 2 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Tao Guo, MD, Peking Union Medical College Hospital
Publications and helpful links
General Publications
- Roubein LB. Endoscopic ultrasonography and the malignant esophageal stricture: implications and complications. Gastrointest Endosc. 1995 Jun;41(6):613-5. doi: 10.1016/s0016-5107(95)70205-9. No abstract available.
- Jenssen C, Alvarez-Sanchez MV, Napoleon B, Faiss S. Diagnostic endoscopic ultrasonography: assessment of safety and prevention of complications. World J Gastroenterol. 2012 Sep 14;18(34):4659-76. doi: 10.3748/wjg.v18.i34.4659.
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
Keywords
Other Study ID Numbers
- 2017YFC0109804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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