Assessment of the Echoendoscope for Clinical Performance

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Endosonography

Treatments: Other: Assessment of the safety and validity of echoendoscope

Study type: Observational

Funder types: Other

Identifiers

NCT04161950

2017YFC0109804

Details and patient eligibility

About

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.

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 Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.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

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

Tested device model (EG-UR5-S50 )

Description:

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.

Treatment:

Other: Assessment of the safety and validity of echoendoscope

Compared device model (GF-UE260-ME2)

Description:

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

Treatment:

Other: Assessment of the safety and validity of echoendoscope