None listed
Conditions
Interventions
Medical Device : This clinical trial is a multi-center, prospective, randomized, single-blind, non-inferiority study designed to evaluate the efficacy and safety of the high-resolution motorized flexi
Sponsors
MedInTech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for participation in this clinical trial, all of the following inclusion criteria must be met: 1) Individuals aged between 19 and 70 years at the time of informed consent; 2) Individuals in good health who wish to undergo gastroscopy for screening purposes; 3) Individuals who have voluntarily signed the informed consent form; 4) Individuals who are capable of understanding and complying with the study procedures and visit schedule.
Exclusion criteria
Exclusion criteria: An individual will be excluded from participation in this clinical trial if they meet any of the following exclusion criteria: 1) Individuals who meet one or more contraindications for upper gastrointestinal endoscopy, including: ? Difficulty in endoscope insertion due to ENT disorders or strictures of the pharynx or upper esophagus; ? Suspected gastrointestinal perforation or bleeding; ? Recent acute myocardial infarction, or severe cardiovascular diseases such as arrhythmia, heart failure, or aortic aneurysm; ? Acute corrosive esophagitis caused by ingestion of strong acids, alkalis, or other chemical agents; ? Loose teeth or conditions that may increase the risk of dental injury during the procedure; ? A medical history that suggests risk of respiratory complications during sedation (e.g., chronic obstructive pulmonary disease, cerebrovascular disease, neuromuscular disorders, or presence of a tracheostomy cannula). 2) Individuals with known hypersensitivity or allergic reactions to the sedatives used during the procedure. 3) Individuals with platelet function disorders, coagulation disorders, or those currently taking anticoagulants (e.g., warfarin, heparin, or direct oral anticoagulants) or antiplatelet agents (except those taking low-risk agents such as aspirin). 4) Individuals with a history of gastric surgery, including total or subtotal gastrectomy, gastrointestinal obstruction, or endoscopic submucosal dissection (ESD). 5) Individuals with a history, within the past 6 months, of alcohol or drug abuse accompanied by cognitive impairment, or serious neurological or psychiatric disorders. 6) Any other individuals deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total procedure time | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant satisfaction;Operator usability;Operator mental workload (NASA Task Load Index, NASA-TLX);Safety outcomes | — |
Countries
Korea, Republic of
Contacts
Public ContactSeoyeon Lee
Seoul National University Hospital
Outcome results
None listed