Johnson & Johnson Concludes OTTAVA Robotic Surgery System Trial

Johnson & Johnson developed OTTAVA for procedures like gastric bypass surgery. Source: Adobe Stock

Johnson & Johnson has announced the results from the first clinical study of its investigational OTTAVA robotic surgical system. This prospective, multicenter study assessed the system's safety and performance in Roux-en-Y gastric bypass procedures.

In the 30-patient study, the primary safety and performance goals were met at the 30-day post-operative mark, according to J&J. Surgeons completed all procedures robotically using OTTAVA without needing to switch to a non-robotic technique. Patients experienced an average weight loss of 30 pounds (13.6 kg) within 30 days after surgery.

“The data provides encouraging evidence for the safety and performance of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures,” said Dr. Erik Wilson. Dr. Wilson is chief of minimally invasive and elective general surgery at UTHealth Houston, director of bariatric surgery at Memorial Hermann-Texas Medical Center, and the lead investigator for the clinical study.

“Continued innovation in bariatric surgery is crucial for patient care, and I am pleased to share these initial clinical findings,” he added.

The company has used this clinical data, along with preclinical testing, to support an application to the U.S. Food and Drug Administration (FDA) for De Novo classification. J&J is seeking an indication that covers multiple general surgery procedures within the upper abdomen, including gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.

The New Brunswick, N.J.-based company presented these results at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting (Abstract 4153).

OTTAVA's development was delayed by the COVID-19 pandemic. The FDA granted the system an investigational device exemption (IDE) in late 2024, and it completed its first surgical cases approximately one year ago.

J&J targets soft-tissue surgery with its latest system

Johnson & Johnson designed OTTAVA as a multi-specialty robotic system for soft-tissue surgery. The company states it enables a wide range of procedures across various surgical specialties, with multiple clinical trials planned to support these applications.

The system features a novel architecture that integrates four robotic arms directly into a standard-sized surgical table, eliminating the need for separate booms or equipment carts.

In this study, OTTAVA was successfully installed and used in operating rooms across six participating hospitals. The OR sizes varied from approximately 243 to 694 square feet (22.5 to 64.4 square meters).

At five of the six sites, procedures were performed in operating rooms that had not previously been used for robotic surgery, including spaces historically considered challenging for robotic systems due to size limitations.

“Our progress with OTTAVA is built on rigorous preclinical work, disciplined clinical data collection, and close collaboration with the surgeons using it—particularly the investigators in the FORTE clinical study,” said Dr. Peter Schulam, Ph.D., chief scientific officer for MedTech at Johnson & Johnson. “These results further demonstrate how its novel architecture supports a differentiated approach where it matters most: in real operating rooms with real patients.”

“At every stage—from bench testing to preclinical and now human trials—we have seen that this system can enable more hospital ORs to incorporate robotics,” he noted. “These findings show the novel architecture can integrate into existing infrastructure and help overcome practical barriers to wider adoption.”

Inside the FORTE study of OTTAVA

In the United States alone, over 40% of adults have obesity. Johnson & Johnson notes that metabolic and bariatric surgical procedures are effective, long-term treatment options for weight management.

Many of these procedures, including Roux-en-Y gastric bypass, are increasingly performed with robotic assistance. Roux-en-Y gastric bypass is a critical intervention for managing obesity, with recent research indicating it is among the most effective and durable treatments for severe obesity.

The operation is technically demanding compared to other bariatric procedures. It requires both restrictive and reconstructive steps that typically involve multiple abdominal quadrants and 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 U.S. study sites.

The study aims to evaluate the safety and performance of OTTAVA up to 30 days after Roux-en-Y gastric bypass surgery. J&J included data from the FORTE study, along with supporting preclinical testing, in its application to the FDA for De Novo classification.

The OTTAVA Robotic Surgical System is currently under development and is not yet authorized for marketing or sale in any market, the company stated.

Editor’s note: The Robotics Summit & Expo this month is co-located with DeviceTalks Boston. Register now to attend.