Johnson & Johnson has announced results from the first clinical study of the investigational OTTAVA Robotic Surgical System, evaluating the system’s safety and performance in Roux-en-Y gastric bypass procedures.
The results were presented at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting.
In the 30-patient cohort, the study met its primary safety and performance endpoints at 30 days post-procedure, and investigators completed all procedures robotically on OTTAVA without converting to a non-robotic approach.
The average weight loss at 30 days after surgery was 30 pounds.
The clinical data, together with preclinical testing, were used to support an application to the US FDA for De Novo classification 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.
Erik Wilson, chief of minimally invasive and elective general surgery, UTHealth Houston, director of bariatric surgery at the Memorial Hermann-Texas Medical Centre, and lead investigator for the clinical study, said: ‘The data show encouraging evidence regarding the safety and performance of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures. Continued innovation in bariatric surgery is important to patient care, and I am pleased to present these initial clinical results.’
Roux-en-Y gastric bypass is an essential intervention in the management of obesity, with recent research indicating that it 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.
Hani Abouhalka, company group chair, Surgery, MedTech, Johnson & Johnson, said: ‘This is an exciting milestone for our programme as we share the role of OTTAVA as a robotic surgical system with a novel architecture supporting patient treatment during the clinical trial.
‘This work also underscores our long-term commitment to bariatric surgeons and to equipping clinicians with a broad portfolio of surgical technologies to address the complexity of obesity care. Across open, laparoscopic, and robotic surgery, we remain focused on translating innovation into real-world solutions that help surgeons broaden access to precision surgical care and improve outcomes for patients.’
OTTAVA is designed as a multi-specialty soft-tissue surgery robot, built to enable a broad range of procedures across multiple specialties, to be supported with multiple clinical trials.
The system integrates four robotic arms into a standard-sized surgical table, eliminating the need for a separate boom or carts.
In this study, OTTAVA was installed and used successfully across operating rooms (ORs) at all six participating hospitals. OR sizes ranged from approximately 243 to 694 square feet.
At five of the six sites, procedures were performed in ORs that had not previously been used for robotic surgery, including rooms historically considered challenging for robotic systems due to space constraints.
Peter Schulam, chief scientific officer, MedTech, Johnson & Johnson, said: ‘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. These results further illustrate how novel architecture supports a differentiated approach where it matters most: in real operating rooms, with real patients.’
The OTTAVA Robotic Surgical System is under development and is not yet authorised for marketing or sale.
