| CTRI Number |
CTRI/2026/03/106229 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study of a Pulsed Field Ablation for Type 2 Diabetes |
|
Scientific Title of Study
|
Platform Study of Gastrointestinal Pulsed Electric Field Ablation with Initial Evaluation in Adults with Type 2 Diabetes |
| Trial Acronym |
GASTRO-PEF T2D |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kalapala |
| Designation |
Director of Endoscopy at the Centre for Obesity and Metabolic Therapy |
| Affiliation |
AIG Hospitals |
| Address |
AIG Hospitals, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032, India
Hyderabad
TELANGANA
500032
India |
| Phone |
9989211034 |
| Fax |
|
| Email |
drrakesh.kalapala@aighospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kalapala |
| Designation |
Director of Endoscopy at the Centre for Obesity and Metabolic Therapy |
| Affiliation |
AIG Hospitals |
| Address |
AIG Hospitals, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032, India
TELANGANA
500032
India |
| Phone |
9989211034 |
| Fax |
|
| Email |
drrakesh.kalapala@aighospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Naresh Kumar Pagidimarry |
| Designation |
CEO |
| Affiliation |
8C Healthcare Private Limited |
| Address |
# 1207,First Floor, Street No. 13,
Vijaya Bank Road, Gandhi Nagar,
Hyderabad, Telangana,
Hyderabad
TELANGANA
500080
India |
| Phone |
9866194280 |
| Fax |
|
| Email |
naresh.pagidimarry@8chealthcare.com |
|
|
Source of Monetary or Material Support
|
| Mirai Medical Limited
5 Howley Court, Oranmore, County Galway, H91 P5PH, Ireland |
|
|
Primary Sponsor
|
| Name |
Mirai Medical Limited |
| Address |
5 Howley Court, Oranmore, Galway, H91 P5PH, Ireland |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kalapala |
AIG Hospitals |
1-66/AIG/2 to 5, Centre for Obesity and Metabolic Therapy
Hyderabad
TELANGANA |
9989211034
drrakesh.kalapala@aighospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 catheter, used for non-thermal delivery of PEFs to gastrointestinal mucosa, with the duodenum as the initial anatomical application. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
Safety Endpoint: within the first 30 days after treatment
Exploratory Metabolic Biomarker Endpoint: baseline to 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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)
|
Through 12 months. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [naresh.pagidimarry@8chealthcare.com].
- For how long will this data be available start date provided 02-01-2030 and end date provided 02-01-2040?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
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.
|