Evaluation of the performance of a novel motorization based high-resolution flexible gastroscope system: A prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010918

Enrollment

180

Registered

2025-08-19

Start date

2024-07-19

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

None listed

Interventions

Medical Device : The experimental group will use the high-resolution motorized flexible gastrointestinal endoscope (MEDIUFES Video Gastroscope MGS-400/410) and the endoscopic light source device (MEDI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged between 19 and 70 years - Healthy adults who wish to undergo upper gastrointestinal endoscopy for screening purposes - Individuals who voluntarily agree to participate in the clinical trial and sign the written informed consent form

Exclusion criteria

Exclusion criteria: - Individuals with contraindications to upper gastrointestinal endoscopy: cases in which endoscope passage is difficult due to otolaryngologic disease or stenosis of the pharynx or upper esophagus, unstable vital signs, impaired consciousness, recent corrosive ingestion, suspected gastrointestinal perforation, peritonitis, gastrointestinal obstruction, or recent gastrointestinal surgery - Patients with suspected recent gastrointestinal bleeding - Patients who have previously undergone endoscopic submucosal dissection - Individuals with a history of gastric surgery - Patients with severe cardiopulmonary disease - Patients with mental or cognitive impairment - Individuals with platelet function disorders or coagulopathy - Patients currently taking antithrombotic or anticoagulant agents - Pregnant women - Patients with abdominal or iliac aortic aneurysm - Individuals with hypersensitivity to sedatives used during the examination - Any other individual deemed by the investigator to be unsuitable for participation in the clinical trial

Design outcomes

Primary

Measure	Time frame
Ease of manipulation assessment	—

Secondary

Measure	Time frame
Patient satisfaction on the day of the examination and at day 7;Endoscopist’s mental workload (NASA-TLX);Image quality;Post-examination complications	—

Countries

Korea, Republic of

Contacts

Public ContactSeoyeon Lee

Seoul National University Hospital

lsy6758@snu.ac.kr+82-2-2072-2114

Outcome results