Platform Study of Gastrointestinal Pulsed Electric Field Ablation with Initial Evaluation in Adults with Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The ePORE® system is a pulsed electric field (PEF) platform intended for endoscopic delivery of controlled pulsed electric fields to gastrointestinal mucosa. The system consists primarily of the reusable ePORE® generator and the single-use GASTRO-PEF catheter, which is introduced through the working channel of a compatible therapeutic endoscope.
The ePORE® generator is a compact, mains-powered, desktop unit that sits adjacent to the endoscopy bed. It delivers pre-programmed sequences of very short, precisely controlled electrical pulses through the connected catheter to the target mucosa. The pulse parameters are configured to achieve ablation with a “non-thermal” mechanism of action. The system is designed for use in a monitored endoscopy suite under deep sedation or anaesthesia.
In this clinical investigation, the system is used to deliver pulsed electric fields to the upper gastrointestinal mucosa, with the duodenum selected as the initial target anatomy. During the procedure, the endoscopist advances a standard therapeutic endoscope to the duodenum and then introduces the GASTRO-PEF catheter through the 3.7 mm working channel. Once the catheter tip is positioned at the target segment, an expandable electrode at the distal end of the catheter is deployed. This electrode self-expands to gently contact the duodenal mucosa circumferentially, creating a stable and reproducible electrode–tissue interface.
At each treatment position, the ePORE® generator delivers a fixed train of pulses over a period of a few seconds. The electrode geometry and pulse parameters are co-optimised so that the electric field is distributed evenly around the circumference, with ablation confined predominantly to the mucosal layer and superficial submucosa, while preserving deeper wall structures. Following pulse delivery, the electrode is collapsed, the catheter is repositioned proximally or distally, and the process is repeated in short segments until the planned length of duodenum has been treated. At the end of the procedure, the catheter and endoscope are withdrawn and the single-use catheter is disposed of in accordance with hospital protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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 m².
- •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.
排除标准
- •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.
- •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.
研究者
Dr Rakesh Kalapala
AIG Hospitals