Aqua Medical has treated the first West Coast patient in the RESTORE-I trial, a Food and Drug Administration (FDA)-approved investigational device exemption (IDE) study assessing its proximal intestinal mucosal ablation (PIMA) procedure for adults with type 2 diabetes (T2D).
The treatment took place at Hoag Hospital in Newport Beach, California, making this patient the second enrolled in the study overall. The multi-centre study is taking place at four locations in the US.
The PIMA procedure uses Aqua Medical’s radiofrequency vapour ablation (RFVA) platform.
Delivered through a standard endoscope’s working channel, the technique targets a segment of the proximal small intestine.
It aims to address abnormal metabolic signalling connected to insulin resistance, with the intention of promoting mucosal regeneration and studying its impact on metabolic control.
The procedure is minimally invasive, performed on an outpatient basis without the need for surgery or fluoroscopy, and fits within current endoscopy practices.
It was performed by Hoag Hospital interventional endoscopist Jennifer Phan, who is also vice-president of Women in Endoscopy.
Clinical co-investigators at Hoag Hospital include Hoag Digestive Health Institute executive medical director Kenneth Chang and Hoag endocrinologist and diabetes services chief David Ahn.
Aqua Medical chief medical officer Raj Nihalani said: “We believe this technology could change how metabolic disease is treated. A procedure delivered through the working channel of a standard endoscope, with no fluoroscopy required, has the potential to make advanced metabolic therapy accessible to far more patients.
“Early clinical experience has been encouraging, and this study is designed to evaluate those observations rigorously.”
Patient recruitment for the trial remains ongoing at all participating locations. The trial is designed to assess the safety and effectiveness of the PIMA procedure in patients with inadequately controlled T2D despite standard therapy.
Use of the RFVA system for PIMA is investigational and not yet established as safe or effective for this purpose.
