Assessment of the Echoendoscope for Clinical Performance

NCT04161950 | Completed

• 1 other identifier: 2017YFC0109804
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Endosonography

Keywords

echoendoscope; endoscopic ultrasonography

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Device controllability Assessment

  up to 2 months

• System safety assessment

  up to 2 months

• System stability assessment

  up to 2 months

Study Arms (2)

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.

Other: Assessment of the safety and validity of echoendoscope

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.

Other: Assessment of the safety and validity of echoendoscope

Interventions

Assessment of the safety and validity of echoendoscope OTHER

1. Ultrasonic and endoscopic image quality assessment 2. Device controllability assessment 3. System safety assessment 4. System stability assessment

Compared device model (GF-UE260-ME2); Tested device model (EG-UR5-S50 )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.

You may qualify if:

• The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
• Patients volunteering to participate in this study and sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Gastroenterology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• 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.

  PMID: 7672562 BACKGROUND

• 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.

  PMID: 23002335 BACKGROUND

Study Officials

• Tao Guo, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor in Department of Gastroenterolgy

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 13, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: February 22, 2022
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)