Clinical trial NCT04161950: Assessment of the Echoendoscope for Clinical Performance
Official title: Prospective Comparison of Two EUS System for Clinical Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endosonography
Keywords: echoendoscope
endoscopic ultrasonography
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.

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 Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.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 gastrointesinal 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasonic Image Quality Assessment
timeFrame: up to 2 months
measure: Endoscopic Image Quality Assessment
timeFrame: up to 2 months
Secondary outcomes:
measure: Device controllability Assessment
timeFrame: up to 2 months
measure: System safety assessment
timeFrame: up to 2 months
measure: System stability assessment
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Gastroenterology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Tao Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.