Johnson & Johnson has developed OTTAVA for procedures such as for gastric bypass. Source: Adobe Stock
Johnson & Johnson announced results from the first clinical study of the investigational OTTAVA robotic surgical system. The prospective, multicenter clinical study evaluated the safety and performance of the system for gastric-bypass procedures.
In the 30-patient cohort, the study met its primary safety and performance endpoints through 30 days post-procedure, said J&J. Investigators completed all procedures robotically on OTTAVA without conversion to a non-robotic approach. Average weight loss by 30 days after surgery was 30 lb. (13.6 kg).
“The data show encouraging evidence regarding the safety and performance of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures,” stated Erik Wilson, M.D. He is chief of minimally invasive and elective general surgery at UTHealth Houston, director of bariatric surgery at 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,” added Wilson.
The company used this clinical data, together with preclinical testing, to support an application to the U.S. Food and Drug Administration (FDA) for De Novo classification. J&J is targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.
The New Brunswick, N.J.-based company presented its results at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting (Abstract 4153).
Development of OTTAVA was delayed because of the COVID-19 pandemic, the FDA granted OTTAVA an investigational device exemption (IDE) in late 2024. The system completed its first cases a year ago.
J&J targets soft-tissue surgery with its latest system
Johnson & Johnson designed OTTAVA as a multi-specialty soft-tissue surgical robot. The company said it enables a broad range of procedures across multiple specialties. Multiple clinical trials will support these specialties.
The system’s novel architecture incorporates four robotic arms integrated into a standard-size surgical table, removing the need for a separate boom or carts.
In this study, OTTAVA was installed and used successfully across operating rooms at six participating hospitals. OR sizes ranged from approximately 243 to 694 sq. ft. (22.5 to 64.4 sq. m).
In five of the six sites, OTTAVA performed procedures in ORs that previously had not been used for robotic surgery, including rooms historically considered challenging for robotic systems due to space constraints.
“Our progress with OTTAVA relies on rigorous preclinical work, disciplined data collection in the clinic, and tight collaboration with the surgeons who use it – especially the investigators in the FORTE clinical study,” said Peter Schulam, M.D., Ph.D., and chief scientific officer for MedTech at Johnson & Johnson. “These results further illustrate how novel architecture supports a differentiated approach where it matters most: in real operating rooms, with real patients.”
“At each step – from bench to preclinical and now human trial – we have observed that this system can allow more hospital ORs to accommodate robotics,” he said. “These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption.”
Inside the FORTE study of OTTAVA
In the U.S. alone, more than two in five adults have obesity. Metabolic and bariatric surgical procedures are effective, long-term treatment options for weight loss management, said Johnson & Johnson.
Many of these procedures, including Roux-en-Y gastric bypass, are increasingly performed robotically. Roux‑en‑Y gastric bypass is an essential intervention in the management of obesity, with recent research indicating the treatment is most effective and durable for severe obesity.
The operation is technically demanding relative to other bariatric procedures – requiring both restrictive and reconstructive steps that typically span multiple abdominal quadrants and leveraging a broad spectrum of surgical tasks.
The Safety and Performance of the OTTAVA Robotic System: A Prospective Multi-Center Evaluation (FORTE) Study (NCT06709261) is a single-arm, open-label clinical trial conducted across six study sites in the U.S.
The purpose of the study is to evaluate the safety and performance of OTTAVA through 30 days after Roux-en-Y gastric bypass surgery. J&J included data from the FORTE study, together with supporting preclinical testing, in its application for FDA De Novo classification.
The OTTAVA Robotic Surgical System is under development and is not yet authorized to be marketed or sold in any market, noted the company.
Editor’s note: The Robotics Summit & Expo this month is co-located with DeviceTalks Boston. Register now to attend.
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