Hoag Memorial Hospital Presbyterian Treats First U.S. Patient in FDA-Authorized Clinical Trial of Investigational Endoscopic Therapy for Type 2 Diabetes
Hoag is one of four sites nationwide selected to evaluate Aqua Medical’s minimally invasive endoscopic therapy for type 2 diabetes
The device has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE)
The procedure uses controlled vapor ablation to resurface a portion of the small intestine
Early international studies have demonstrated meaningful improvements in glucose control
NEWPORT BEACH, Calif. (July 13, 2026) — Hoag today announced it has treated the first patient in the nation in a clinical study evaluating an investigational endoscopic procedure designed to improve glucose control in patients living with type 2 diabetes. Hoag is one of only four centers in the United States selected to participate in the FDA-authorized study.
The minimally invasive procedure uses radiofrequency vapor ablation (RFVA) delivered through an endoscope to resurface a small section of the duodenum — the first portion of the small intestine. The device is investigational and has not been approved by the FDA for commercial use or treatment of type 2 diabetes.
International clinical trials have shown the procedure may help reduce HbA1c levels, a key marker used to measure long-term glucose control and improve metabolic regulation in appropriate patients.
“As diabetes care evolves, it is critical that we continue to explore therapies beyond medication alone,” said Jennifer Phan, MD, Medical Director of the Hoag Irvine Advanced Endoscopy Center and Principal Investigator of the study at Hoag. “This study allows us to evaluate an approach that may complement existing medical management, particularly for patients whose diabetes remains difficult to control.”
Type 2 diabetes affects millions of Americans, and many patients struggle to achieve adequate glucose control despite oral medications and lifestyle changes. While GLP-1 therapies have expanded treatment options, some patients are unable to tolerate them, may not achieve sufficient control, or prefer non-drug alternatives. This clinical trial will evaluate whether targeted resurfacing of the duodenal lining can offer another pathway to improved metabolic stability.
Researchers believe that over time, changes in the mucosal lining of the small intestine may contribute to impaired glucose regulation. The investigational procedure gently ablates a thin surface layer of tissue, prompting regeneration of healthier mucosa that may support improved insulin signaling and glycemic control.
“One of the distinguishing features of this technology is that it can be delivered endoscopically, without surgery,” said Kenneth Chang, MD, James & Pamela Muzzy Executive Medical Director Endowed Chair in GI Cancer, Digestive Health Institute, at Hoag. “If proven effective, this approach could expand access to a non-surgical option for patients with uncontrolled diabetes.”
The study is being conducted in collaboration with Hoag’s multidisciplinary diabetes care team, including endocrinology and advanced endoscopy specialists, ensuring that participants receive comprehensive evaluation and ongoing medical oversight. Philanthropic support has helped advance Hoag's clinical research enterprise, enabling physicians to evaluate promising new therapies and expand patient access to innovative clinical trials.
“This trial reflects Hoag’s commitment to advancing metabolic care through thoughtful, evidence-based innovation,” said David T. Ahn, MD, Dr. Kris V. Iyer Endowed Chair in Diabetes Care and Chief of Diabetes Services at Hoag. “By participating in early-stage research, we can responsibly evaluate emerging therapies while maintaining our focus on patient safety and outcomes.”
Raj Nihalani, M.D., Chief Medical Officer of Aqua Medical, said Hoag’s privademic model – which combines the rigor of an academic institution with agile and patient-centric care – led to the hospital’s selection as one of only four sites in the nation to test the new technology.
“We believe this technology could fundamentally change how metabolic disease is treated,” Raj said. “A simple, through-the-scope procedure requiring no fluoroscopy, combined with encouraging early insulin elimination data, has the potential to make advanced metabolic therapy accessible to many more patients.”
The study will enroll adults with type 2 diabetes whose condition remains inadequately controlled despite standard medical therapy. Interested patients should contact Cadence Cooper at cadence.cooper@hoag.org.
