Endosonography Clinical Trial
Official title:
Prospective Comparison of Two EUS System for Clinical Performance
Verified date | March 2022 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | February 22, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Jenssen C, Alvarez-Sánchez MV, Napoléon B, Faiss S. Diagnostic endoscopic ultrasonography: assessment of safety and prevention of complications. World J Gastroenterol. 2012 Sep 14;18(34):4659-76. Review. — View Citation
Roubein LB. Endoscopic ultrasonography and the malignant esophageal stricture: implications and complications. Gastrointest Endosc. 1995 Jun;41(6):613-5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultrasonic Image Quality Assessment | 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 | |
Primary | Endoscopic Image Quality Assessment | 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 | Device controllability Assessment | 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 | |
Secondary | System safety assessment | 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 | |
Secondary | System stability assessment | 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 |
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