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Efficiency and safety of newly designed water-balloon free versus traditional linear ultrasonic endoscope in the diagnosis of digestive disorders: a randomized, multicenter, open-label, non-inferiority phase 3 Trial

Efficiency and safety of newly designed water-balloon free versus traditional linear ultrasonic endoscope in the diagnosis of digestive disorders: a randomized, multicenter, open-label, non-inferiority phase 3 trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043712
Enrollment
Unknown
Registered
2021-02-27
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Disease

Interventions

A:newly designed water-balloon free linear EUS
B:traditional linear EUS

Sponsors

Shengjing Hospital Affiliated to China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who need to be examined, diagnosed or treated by ultrasound electronic upper gastrointestinal endoscopy; 2. Subjects aged 18-70 years old; 3. Subjects of any gender; 4. The volunteers participated in the experiment voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients with mental disorders can not cooperate with the examiners; 2. Patients with severe cardiopulmonary diseases who cannot tolerate endoscopy, such as severe cardiac insufficiency, severe pulmonary insufficiency, and severe arrhythmia; 3. Patients in critical condition such as shock; 4. Patients with suspected or confirmed upper gastrointestinal perforation or perforation in acute stage; 5. Patients with acute gastric and esophageal chemical and corrosive injury; 6. Patients considered unsuitable for this trial by the researchers.

Design outcomes

Primary

MeasureTime frame
Ultrasound image quality evaluation;

Countries

China

Contacts

Public ContactSiyu Sun

Shengjing Hospital Affiliated to China Medical University

sunsy@sj-hospital.org+86 18940251329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026