EndosonographyNCT04161950
Assessment of the Echoendoscope for Clinical Performance
An observational study of Endosonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endosonography
- What is being tested?
- Assessment of the safety and validity of echoendoscope
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.
Who may be able to join
- The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
- Patients volunteering to participate in this study and sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Prospective Comparison of Two EUS System for Clinical Performance
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.
Read the 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.
- 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.
- 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.
- Conditions
- Endosonography
- Being tested
- Assessment of the safety and validity of echoendoscope
- Keywords
- echoendoscope, endoscopic ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the safety and validity of echoendoscopeOther
- Ultrasonic and endoscopic image quality assessment
- Device controllability assessment
- System safety assessment
- System stability assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Assessment of the safety and validity of echoendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: up to 2 months
Secondary outcomes (3)
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%.
Measured: up to 2 months
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.
Measured: up to 2 months
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%.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Nov 2019
- Primary completion31 Dec 2021
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndosonographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Guo, Peking Union Medical College Hospital
- Investigators
- Tao Guo, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161950
- Sponsor's protocol ID
- 2017YFC0109804
- Status last verified
- May 2025
- First submitted
- 10 Nov 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data are private.
Publications
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.
PubMed 7672562Jenssen 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.
PubMed 23002335
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Two EUS System for Clinical Performance
- ClinicalTrials.gov ID
- NCT04161950
- Acronym / sponsor ID
- 2017YFC0109804
- Conditions
- Endosonography
- Keywords
- echoendoscope, endoscopic ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested device model (EG-UR5-S50 ) | – | Other: Assessment of the safety and validity of echoendoscopeTested 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) | – | Other: Assessment of the safety and validity of echoendoscopeCompared device model: The GF-UE260 echoendoscope manufactured by Olympus and its compatible light source, image processor and ME2 ultrasonic processor. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to PUMCH Endoscopy Unit for EUS assessment will be included.
Key inclusion criteria (2 listed)
- The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
- Patients volunteering to participate in this study and sign the informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the safety and validity of echoendoscope1. Ultrasonic and endoscopic image quality assessment 2. Device controllability assessment 3. System safety assessment 4. System stability assessment | Other | Compared device model (GF-UE260-ME2), Tested device model (EG-UR5-S50 ) |
Primary outcome
Ultrasonic Image Quality Assessment
Time frame: 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
Time frame: 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%.
3 secondary outcomes
Device controllability Assessment
Time frame: up to 2 months
System safety assessment
Time frame: up to 2 months
System stability assessment
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 7672562Roubein 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.
- Background: PubMed 23002335Jenssen 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.
- Individual participant dataSharing planned: No. The individual participant data are private.
Related trials for Endosonography
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography
Pancreatic Cystic Lesion (PCL)
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Guo, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endosonography, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonic Image Quality Assessment (time frame: up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161950, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.