Johnson & Johnson’s Ottava Robot Meets Endpoints in Pivotal Bariatric Surgery Trial

Johnson & Johnson has released results from the first clinical study of the investigational Ottava robotic surgical system.

The prospective, multicenter clinical study is assessing the system’s safety and performance in Roux-en-Y gastric bypass procedures. The results were presented at this year’s American Society for Metabolic and Bariatric Surgery (ASMBS) annual meeting.

In the 30-patient cohort, the study met primary safety and performance endpoints through 30 days post-procedure. Investigators also completed all the procedures robotically on Ottava without converting to a non-robotic approach.

“This is an exciting milestone for our program as we share the role of OTTAVA as a robotic surgical system with a novel architecture supporting patient treatment during the clinical trial,” said Hani Abouhalka, company group chair, Surgery, MedTech, Johnson & Johnson. “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.”

The average weight loss by 30 days after surgery was 30 pounds. The clinical data, together with preclinical testing, were leveraged to support an application to the U.S. Food and Drug Administration for De Novo classification. The indication being targeted includes multiple procedures in general surgery in the upper abdomen, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

Ottava was installed and successfully used across operating rooms at all six participating hospitals. OR sizes varied from about 243 to 694 square feet. In five of the six sites, procedures were done in Ors that hadn’t previously been used for robotic surgery—including rooms historically considered difficult for robotic systems because of 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. These results further illustrate how novel architecture supports a differentiated approach where it matters most: in real operating rooms, with real patients,” said Peter Schulam, M.D., PhD, chief scientific officer, MedTech, Johnson & Johnson. “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. These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption.”