A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control

A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control

experiment design: Single-center, single-arm, open-label trial

Inclusion Criteria:

1. Ages 18-70.
2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
3. The glycated hemoglobin level is 7.5%-10.5%.
4. BMI 2 7-40 kg/m2.
5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
6. Stable body weight (defined as a weight change of <5% within 5 weeks prior to screening)
7. Donation of blood is prohibited during the trial participation period.
8. The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
9. Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
10. Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.

Primary efficacy endpoint :HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment Observation period: 6 months postoperatively. Secondary efficacy endpoint HbA1c: The difference in HbA1c levels from the baseline period to after treatment Observation periods: 1 month, 3 months, and 12 months post-treatment. Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Weight: Average weight from the baseline period to post-treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.

Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Safety Indicator 1. Adverse Events and Serious Adverse Events 2. Device defect 3. Intraoperative Instrument Performance Evaluation

Inclusion Criteria:

1. Ages 18-70.
2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
3. The glycated hemoglobin level is 7.5%-10.5%.
4. BMI 2 7-40 kg/m2.
5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
6. Stable body weight (defined as a weight change of <5% within 5 weeks prior to screening)
7. Donation of blood is prohibited during the trial participation period.
8. The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
9. Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
10. Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.

Exclusion Criteria:

1. Diagnosed with type 1 diabetes mellitus.
2. Severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma.
3. Fasting serum C-peptide <1 ng/mL (333 pmol/L).
4. Over the past two years, insulin of any type has been used for more than 1 month (excluding treatment for gestational diabetes mellitus).
5. History of ≥1 severe hypoglycemic episode within the past 6 months (defined as requiring assistance from a third party).
6. Currently using a GLP-1RA or a dual GLP-6/GIP agonist.
7. Known autoimmune diseases.
8. Previous gastrointestinal surgery that has altered the anatomical structure of the digestive tract or may limit duodenal resection, such as Billroth II, Roux-en-Y gastric bypass, gastric banding, or other similar procedures/diseases.
9. A known history of upper gastrointestinal structural or functional disorders may impede device passage through the upper gastrointestinal tract or increase the risk of tissue injury during endoscopic procedures, including upper gastrointestinal strictures, esophageal-gastric varices, large diverticula, or other severe esophageal, gastric, or duodenal pathologies.
10. History of gastroparesis.
11. Acute gastrointestinal disease has occurred within the past 7 days.
12. A history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel diseases such as Crohns disease and celiac disease is known.
13. Previous history of chronic or acute pancreatitis.
14. Active hepatitis or active liver disease, or an alanine aminotransferase (ALT) level>3.0 times the upper limit of normal (ULN) as determined by the central laboratory during screening evaluation.
15. Currently, vitamin K antagonists such as warfarin are being used, or oral anticoagulants (DOCA) that cannot be safely discontinued are being administered.
16. Patients currently using P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued within 7 days prior to surgery.
17. Nonsteroidal anti-inflammatory drugs (NSAIDs) must not be discontinued within 4 weeks after treatment. Alternative use of acetaminophen and low-dose aspirin is permitted.
18. Systemic glucocorticoids (excluding topical, ocular, or inhaled formulations) were administered continuously for more than 12 days within 10 weeks prior to screening.
19. Use medications known to affect gastrointestinal motility
20. Individuals currently using weight-loss medications or over-the-counter weight-loss drugs.
21. Participate in any structured weight loss program or endoscopic weight loss intervention within 6 months after screening.
22. Persistent anemia, defined as hemoglobin <10 g/dL.
23. Known hemoglobinopathies, hemolytic anemia or sickle cell anemia, or other known hemoglobin abnormalities that may interfere with HbA1c measurement.
24. A history of blood donation or transfusion within 3 months prior to screening.
25. Unstable or paroxysmal arrhythmia.
26. Any of the following cardiovascular diseases occurred within 6 months prior to screening: acute myocardial infarction (AMI), cerebrovascular accident (stroke), or hospitalization due to congestive heart failure.
27. History of valvular heart disease or chronic heart failure (NYHA class III or IV).
28. Individuals with known immunocompromised status, including but not limited to those who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, those with clinically significant leukopenia, those who are positive for human immunodeficiency virus (HIV), or whose immune status makes them unsuitable for clinical trial participation as determined by the investigators.
29. There is secondary hypothyroidism or poorly controlled primary hypothyroidism (TSH levels exceed the normal range during screening).
30. During the examination, do not implant any electronic devices that cannot be turned off (such as implantable cardiac pacemakers).
31. A duodenal or biliary stent is in place.
32. Patients with contraindications to upper gastrointestinal endoscopy or intravenous anesthesia.
33. Currently diagnosed with malignant tumor or with a history of malignant tumor within the preceding 5 years (excluding non-melanoma skin cancer that has received adequate treatment with no evidence of recurrence at least 3 months prior to the study intervention, or treated cervical carcinoma in situ with no evidence of recurrence at least 3 months prior to the study intervention).
34. Breastfeeding women.
35. The participant is currently enrolled in another ongoing clinical trial.
36. Binge eating disorder; a history or presence of severe, progressive, or uncontrolled renal, genitourinary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatic, neurological, psychiatric disorders, or metabolic disturbances; or any other psychological or physical condition deemed by the investigator to render the participant unsuitable for participation in the clinical trial.
37. The patient is in critical condition or has an expected lifespan of less than 5 years.