Gastrointestinal Polyps
Conditions
Interventions
Experimental Group:Participants in the experimental group will undergo the procedure performed by the investigator using the investigational device, the Endoscopic Surgical Instrument Control System,
Control Group:Participants in the control group will undergo the procedure performed by the investigator in collaboration with the instrument nurse using conventional manual endoscopic instruments (el
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants enrolled in this clinical trial must meet all of the following criteria: 1. Aged 18 to 75 years, inclusive, regardless of gender; 2. Patients scheduled to undergo biopsy, polypectomy, or polyp removal under digestive endoscopy as confirmed by endoscopic examination; 3. Participants must be able to understand the study objectives, demonstrate sufficient compliance with the study protocol, and voluntarily sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: Participants will be excluded from enrollment if they meet any of the following conditions: 1. For polypectomy: patients with more than 5 polyps requiring resection, or with a polyp longest diameter >20 mm, or with suspected or confirmed submucosal infiltration of malignant lesions. 2. Patients in whom endoscope passage is not feasible or endoscopic treatment is not suitable, such as those with suspected or confirmed acute-phase gastrointestinal perforation, acute gastrointestinal inflammation, stenosis, etc. 3. Patients with severe respiratory diseases, such as acute respiratory tract infection, pneumonia, acute exacerbation of chronic obstructive pulmonary disease or asthma, and obstructive sleep apnea syndrome. 4. Patients with severe coagulation dysfunction (e.g., APTT >1.5 times the upper limit of normal [ULN]) or hemorrhagic diseases. 5. Patients taking anticoagulant or antiplatelet medications who have not met the required washout period prior to the procedure (e.g., discontinuation of P2Y12 receptor antagonists and warfarin for at least 5 days before endoscopy; discontinuation of direct oral anticoagulants for at least 48 hours before endoscopy, etc. [1]). 6. Patients with implanted cardiac pacemakers or metallic heart valves. 7. Patients with known allergies to the investigational products or medications used during the procedure (e.g., anesthetics). 8. Patients judged by the investigator to have severe insufficiency of major organ functions (e.g., brain, heart, lungs, liver, kidneys), such as abnormal liver function (AST/ALT >2× ULN), abnormal renal function (creatinine >1.5× ULN), or uncontrolled diabetes (fasting blood glucose >10 mmol/L), rendering them unable to tolerate the endoscopic procedure. 9. Pregnant or lactating women. 10. Patients who have participated in other drug or medical device clinical trials within 4 weeks prior to screening. 11. Patients considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polypectomy Success Rate;Number of Complete Polypectomies;Procedure time;Postoperative Hospital Stay;Device Performance Evaluation; | — |
Countries
China
Contacts
Public ContactYunsheng Yang
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed