Assessment of the Echoendoscope for Clinical Performance
- Conditions
- Endosonography
- Interventions
- Other: Assessment of the safety and validity of echoendoscope
- Registration Number
- NCT04161950
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- 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 Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
- Patients volunteering to participate in this study and sign the informed consent.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tested device model (EG-UR5-S50 ) Assessment of the safety and validity of echoendoscope 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. Compared device model (GF-UE260-ME2) Assessment of the safety and validity of echoendoscope Compared device model: The GF-UE260 echoendoscope manufactured by Olympus and its compatible light source, image processor and ME2 ultrasonic processor.
- Primary Outcome Measures
Name Time Method Ultrasonic Image Quality Assessment 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%.Endoscopic Image Quality Assessment 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%.
- Secondary Outcome Measures
Name Time Method System stability assessment 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%.
Device controllability Assessment 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%.
System safety assessment 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.
Trial Locations
- Locations (1)
Department of Gastroenterology, Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China