Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: GASTRO-PEF T2D Platform Study: ePORE gastrointestinal pulsed electric field (PEF) ablation platform, consisting of a reusable PEF generator and the GASTRO-PEF single-use endoscopic cat
Sponsors
Mirai Medical Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged greater than 18 years. 2.Able and willing to provide written informed consent. 3.Able to comply with all study procedures and follow-up requirements, including optional CGM if elected. 4.Established diagnosis of Type 2 Diabetes according to ADA/EASD criteria. 5.On stable glucose-lowering therapy for at least 8 weeks prior to screening. 6.HbA1c 7.5 9.5 percent for the initial sentinel/safety cohort; ranges may be broadened during adaptive expansion. 7.BMI 18 40 kg m . 8.Eligible for upper GI endoscopy under sedation or anaesthesia. 9.No prior upper GI surgery or anatomical condition that would prevent safe endoscopic access to the duodenum. 10.Willing to undergo follow-up endoscopies and/or duodenal biopsies.
Exclusion criteria
Exclusion criteria: 1.Use of insulin therapy at screening or within the 3 months prior to baseline. 2.Type 1 diabetes or history of diabetic ketoacidosis. 3.Current or recent use (within 8 weeks) of any GLP-1 based therapy, including dual GIP or GLP-1 agonists (e.g., semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide). 4.Use of other weight-loss medications (e.g., phentermine or topiramate, bupropion or naltrexone). 5.Use of SGLT2 inhibitors within 4 weeks prior to baseline. 6.Recent initiation or dose change (within 8 weeks) of glucose-lowering agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, insulin). 7.Participation in structured or intensive weight-loss programmes within 8 weeks. 8.Prior upper GI surgery preventing safe access to the duodenum (e.g., Roux-en-Y gastric bypass). 9.Active GI ulceration, severe duodenal stenosis, or structural abnormalities compromising safety. 10.Inflammatory bowel disease affecting the duodenum (e.g., Crohn s disease). 11.Coeliac disease. 12.Patients using chronic NSAIDs due to risk of duodenal ulceration or inflammation. 13.Bariatric surgery within 2 years or presence of an endoscopic weight-loss device within 6 months. Hepatopancreatic conditions 14.Clinically significant liver disease, including ALT or AST greater than 3 times ULN, decompensated cirrhosis, or known advanced fibrosis. 15.Chronic pancreatitis, active pancreatic disease, or recent acute pancreatitis (less than 6 months). Safety-related exclusions 16.Coagulation disorders or platelet count below the clinical safety threshold. 17.Contraindications to sedation, anaesthesia, or upper GI endoscopy. 18.Contraindications to CT or MRI, including severe renal impairment affecting contrast use. 19.Women who are pregnant or breastfeeding at screening are excluded 20.Active infection, systemic inflammatory disease, or any uncontrolled medical condition increasing procedural risk. 21.Neurological conditions associated with increased seizure risk (e.g., epilepsy). 22.Active malignancy or a history of malignancy requiring treatment within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cervical carcinoma. Study compliance 23.Participation in another interventional clinical study or use of an investigational product within 30 days or 5 half-lives. 24.Any condition that, in the investigator s opinion, would interfere with adherence to the protocol or required follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: Incidence of device-related SAEs and procedure-related complications within the first 30 days after treatment, assessed according to CTCAE criteria Version 6. Exploratory Metabolic Biomarker Endpoint: Change in HbA1c from baseline to 3 months following gastrointestinal pulsed electric field (PEF) ablation, evaluated descriptively in non-insulin-treated adults with Type 2 Diabetes. Timepoint: Safety Endpoint: within the first 30 days after treatment Exploratory Metabolic Biomarker Endpoint: baseline to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic and Biomarker Outcomes (Exploratory) Gastrointestinal and Tissue Response Patient-Reported Outcomes Technical and Procedural Performance Safety Over Time Body Weight and Anthropometric Outcomes (Exploratory) Glycaemic Pattern and Variability (CGM-Derived, Exploratory) Timepoint: Through 12 months. | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
AIG Hospitals
Outcome results
None listed