RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus (NCT06724822) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus
Chile12 participantsStarted 2024-11-14
Plain-language summary
The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa with RF vapor ablation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects previously enrolled and treated in the STEAM T2DM Clinical study.
. Subjects with improvement in HbA1c of ≤0.5% or with HbA1c of ≥ 7.5% at the 6-month visit while participating in the STEAM T2DM study.
. Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD except for glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.
. Able to comply with study requirements and understand and sign the Informed Consent Form
. Compliance with STEAM T2DM clinical protocol
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.