Study S003386

A Pilot Human Study of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Insulin Requiring Type-2 Diabetes Mellitus

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06655740
Acronym: STEAM-IE
Study type: INTERVENTIONAL
Masking: NONE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 16
Start: 2024-10-01
Primary completion: 2027-06-30
Lead sponsor: Aqua Medical, Inc.
Conditions: Diabetes Mellitus, Type 2
Interventions: DEVICE:RF Vapor Ablation
Results posted: FALSE

Registered primary outcomes

Safety Endpoint [1 month]
Efficacy Endpoint [168 days]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0049101	O79 Discontinuation of exogenous insulin therapy in type 2 diabetes following proximal intestinal mucosal ablation: the STEAM-IE trial Benjamin Norton	2026	Other trial	DOI	cites ClinicalTrials.gov:NCT06655740
R0050185	Proximal intestinal mucosal ablation (PIMA) enables discontinuation of exogenous insulin in type 2 diabetes: final results from the STEAM-IE trial B Norton, Endoscopy	2026	Other trial	DOI	cites ClinicalTrials.gov:NCT06655740
R0048595	895-P: Proximal Intestinal Mucosal Ablation (PIMA) Eliminates the Need for Exogenous Insulin in Type 2 Diabetes—Initial STEAM-IE Trial Results BENJAMIN NORTON, Diabetes	2025	Other trial	DOI	cites ClinicalTrials.gov:NCT06655740