None listed
Conditions
Brief summary
This is a prospective safety and feasibility study of a new device designed to deliver a low electrical pulse to the intestine from inside the body. Candidates for this study will be participants with Type 2 diabetes. This study intends to assess and prove that the device is safe for use for the delivery of energy within the intestine and may be an effective treatment. Participants will be followed up by the study team for up to 1-year post-procedure. This is a non-powered study, so there is no formal hypothesis. This research will determine whether use of this new system is safe and feasible.
Interventions
This is a prospective, single-arm, single centre, interventional study evaluating the safety of a new device designed for the delivery of a low energy pulse to part of the intestine from inside the body. The new device is a gastroscope designed for endoscopic procedures within the gastrointestinal (GI) tract. Structurally and functionally, it resembles conventional gastroscopes used for diagnostic and therapeutic interventions. The device will be inserted through the mouth, and the physician wil
This is a prospective, single-arm, single centre, interventional study evaluating the safety of a new device designed for the delivery of a low energy pulse to part of the intestine from inside the body. The new device is a gastroscope designed for endoscopic procedures within the gastrointestinal (GI) tract. Structurally and functionally, it resembles conventional gastroscopes used for diagnostic and therapeutic interventions. The device will be inserted through the mouth, and the physician will guide the catheter to the location in the duodenum where the treatment will be applied. Upon positioning, energy will be delivered through the study device to the target area specified by the physician. The energy pulse will come from a generator and be delivered by a tool from inside the body that is similar in size to other commonly used tools. The energy provided is a non-thermal ablation that will be delivered through the study device within the duodenum. The duration of energy delivery is approximately 1 minute at each site. The treated lengths can vary across patients. This variability is attributed to user learning curve along with patient anatomical anthropometrics. To account for these factors while maintaining safety, the PANORAMIC protocol allows the user to perform consecutive ablations with minimal gaps to cover the region distal to the major papilla, progressing as distally as feasible based on safe anatomical accessibility. The procedure will last approximately 60 minutes. The treatment will be provided during the study procedure. There will be no additional treatments administered using the study device after the study procedure is completed. The study procedure will be performed by a highly trained gastroenterologist in an endoscopy suite. The gastroenterologist will be trained on the use of the device prior to the start of procedures. No study specific training is needed for any follow-up assessments. Adherence to the intervention will be assessed through follow-up visits performed by the study team as well as a review of medical records.
Sponsors
Ascend Clinical Research Organization, Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Subject is greater than or equal to 22 and less than or equal to 70 years old at the time of enrolment. • Current diagnosis of type 2 disease diagnosed within 10 years of the planned procedure • Subject has an HbA1c between 7.0% and 10.5% • Subject is taking non-insulin diabetes medications. • BMI is greater than or equal to 22 and less than or equal to 45 kg/m2 • Able to comply with study requirements and understand and sign the Informed Consent Form
Exclusion criteria
• American Society of Anesthesia Classification of 4 or higher • Previous gastrointestinal surgery that altered gastrointestinal anatomy including but not limited to Roux-en-Y gastric bypass, sleeve gastrectomy, small bowel surgery/anastomosis and/or altered stomach-duodenum anatomy. • Contraindicated for general anesthetic agents. • Women of child-bearing potential who is pregnant, breastfeeding, lactating, or will not agree to use contraception throughout the duration of study. • Participating in another clinical investigation with an investigational drug or device within three (3) months of enrolment or planned participation at any time during this clinical investigation.
Outcome results
None listed