Robotic Surgical System Enables Gastric Bypass in Space-Constrained Operating Rooms

Obesity affects more than two in five U.S. adults, and surgical interventions remain a durable option when lifestyle and medications fall short. Roux-en-Y gastric bypass is technically demanding, often spanning multiple abdominal quadrants and requiring diverse tasks that many teams now perform robotically. Hospitals also face operating-room space constraints that can complicate robotic access. A new robotic system now demonstrates early clinical performance for Roux‑en‑Y gastric bypass and feasibility in space‑constrained operating rooms.

Johnson & Johnson reported results from the first clinical study of the investigational OTTAVA Robotic Surgical System, a prospective, multicenter evaluation of safety and performance in Roux‑en‑Y gastric bypass. In a 30‑patient cohort, the study met its primary safety and performance endpoints through 30 days, and all procedures were completed robotically on OTTAVA without conversion to a non‑robotic approach. Average weight loss by 30 days after surgery was 30 pounds, and the abstract was presented at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting in San Antonio .

OTTAVA is designed as a multi‑specialty soft‑tissue surgery robot that incorporates four robotic arms into a standard‑size surgical table, removing the need for a separate boom or carts. In the clinical evaluation, the system was installed and used across operating rooms (ORs) at six U.S. hospitals ranging from approximately 243 to 694 square feet. At five of the six sites, procedures occurred in ORs not previously used for robotic surgery, including rooms historically considered challenging for robotics.

Clinical data from this study, together with preclinical testing, were submitted to the U.S. Food and Drug Administration (FDA) to support a De Novo classification application targeting an indication that spans multiple upper‑abdominal general surgery procedures, including gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair. The Safety and Performance of the OTTAVA Robotic System: A Prospective Multi‑Center Evaluation (FORTE) Study (NCT06709261) is a single‑arm, open‑label trial across six U.S. sites assessing safety and performance through 30 days after Roux‑en‑Y gastric bypass. The system remains under development and is not authorized to be marketed or sold in any market.

“The data show encouraging evidence regarding the safety and performance of the OTTAVA™ Robotic Surgical System in Roux-en-Y gastric bypass procedures,” said Erik Wilson, M.D., Chief of Minimally Invasive and Elective General Surgery, UTHealth Houston, Director of Bariatric Surgery, Memorial Hermann-Texas Medical Center, and lead investigator for the clinical study. “Continued innovation in bariatric surgery is important to patient care, and I am pleased to present these initial clinical results.”