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A multi-center clinical observational study on the clinical safety and effectiveness of disposable electronic gastroscope and electronic endoscope image processor for upper gastrointestinal examination

A multi-center clinical observational study on the clinical safety and effectiveness of disposable electronic gastroscope and electronic endoscope image processor for upper gastrointestinal examination

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045101
Enrollment
Unknown
Registered
2021-04-06
Start date
2021-04-06
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Digestive system

Interventions

Disposable gastroscope group:Gastroscopy

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age from 18 to 75 years old, regardless of gender; 2.People undergoing a health checkup; 3.Volunteer to participate in this clinical trial and have signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. People with contraindications to gastroscopy: (1)people with Thoracic and abdominal aortic aneurysm; (2)people with High-grade spinal deformity; (3)people with severe cardiovascular and cerebrovascular diseases; (4)people with severe cardiopulmonary insufficiency; (5)people with huge diverticulum of upper gastrointestinal tract; (6)people with acute inflammation of upper gastrointestinal tract; (7)people with systemic bleeding disorders or abnormal coagulation function and bleeding tendency; (8)people with mental illness or severe intellectual disability. 2. Pregnant and lactating women 3. people who need mergency gastroscopy and/or treatment 4. people who have a history of upper gastrointestinal surgery 5. people who participated in other clinical trials 1 month ago 6. People with a history of allergy to anesthetics 7. people who are not suitable to participate in this trial

Design outcomes

Primary

MeasureTime frame
Reach the anatomical landmarks;

Secondary

MeasureTime frame
confirm whether reaching the anatomical landmarks by Endoangel;Qualified rate of clinical operation experience evaluation of disposable gastroscope;Device failure/defect rate;Operational stability;

Countries

China

Contacts

Public ContactGong Wei

Shenzhen Hospital of Southern Medical University

drgwei@foxmail.com+86 15820290385

Outcome results

None listed

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