None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : - Intervention Type: Device (Medical Device)
- Product Name (Model): Artificial Intelligence–Assisted high-Resolution Motorized Flexible Gastroscopic System (ME-470
Sponsors
MedInTech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 19 to 80 years with a lesion diagnosed via endoscopy and histological examination, which is determined to require therapeutic Endoscopic Submucosal Dissection (ESD) and falls into one of the following categories. 2. Patients who have voluntarily provided written informed consent to participate in the clinical trial. 3. Patients who are capable of fasting for at least 8 hours prior to the procedure. 4. Patients who are eligible to undergo anesthesia and sedation endoscopy.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of prior gastric resection or gastric reconstruction surgery resulting in altered gastric anatomy. 2. Patients in whom endoscopic insertion or ESD is technically difficult due to gastric outlet obstruction, severe stenosis, or deformity. 3. Patients with a bleeding tendency, or those for whom discontinuation of anticoagulants or antiplatelet agents is impossible, resulting in a high risk of intra- or post-operative bleeding. 4. Patients with a lesion considered to have a high risk of perforation, such as an active ulcer, severe fibrosis, or suspected deep invasion. 5. Patients with a lesion suspected of lymph node metastasis or advanced gastric cancer, or a lesion that does not meet the standard indications for ESD. 6. Patients with severe cardiovascular, respiratory, hepatic, or renal disease, placing them in a high-risk group for sedation endoscopy or the procedure itself. 7. Patients with a history of severe hypersensitivity or contraindications to anesthesia or sedatives. 8. Women who are pregnant or breastfeeding, or women of childbearing potential who are not using adequate contraception. 9. Patients who are currently participating or scheduled to participate in another interventional clinical trial prior to or during this study. 10. Patients who, in the investigator's medical judgment, may face undue risk by participating in the trial, or whose participation may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of procedure-related adverse events (including perforation, immediate bleeding, and delayed bleeding) during the procedure and the 4-week post-procedure follow-up period. ;The proportion of successfully completed planned ESD procedures using the investigational device, and the incidence and reasons for conversion. | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate (%) ;En-bloc resection rate (%) ;Total procedure time (from start to end) and specific time for each procedural step (such as incision, dissection, etc.);Operator satisfaction and NASA-TLX | — |
Countries
Korea, Republic of
Contacts
Public ContactHuiwon Shin
Seoul National University Hospital
Outcome results
None listed