Gastric Bypass Using a Surgical Robot with Table-Mounted Arms: First-in-Human Clinical Trial Results with the OTTAVA Robotic Surgical System
This first-in-human clinical trial demonstrated that the OTTAVA Robotic Surgical System with table-mounted arms is safe and effective for performing Roux-en-Y gastric bypass, as all 30 procedures were completed robotically without conversion and met predefined safety and performance goals.
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For decades, surgeons have sought to make complex abdominal operations less invasive, replacing large incisions with tiny ports and long, thin instruments. While standard minimally invasive surgery has been successful, it often requires the surgeon to stand at the patient's side, looking at a two-dimensional screen and manipulating tools that move in the opposite direction of their hands. Robotic surgery was invented to solve these specific problems. By placing a camera and specialized instruments inside the patient and allowing the surgeon to sit at a console, the technology offers a three-dimensional view and instruments that can bend and rotate like a human wrist, mimicking the dexterity of an open surgery but through much smaller openings. For over twenty years, one specific robotic system dominated the market, but the field has recently begun to see new designs emerge, including systems where the robotic arms are built directly into the operating table rather than hanging from a separate cart.
A recent clinical trial set out to test one of these new designs, the OTTAVA Robotic Surgical System, in a procedure known as a Roux-en-Y gastric bypass. This is a major operation used to treat severe obesity, where surgeons create a small stomach pouch and reroute the intestines to help patients lose weight. It is a technically demanding task that requires cutting tissue, sewing internal connections, and working in different areas of the abdomen. The study involved thirty patients across six different hospitals in the United States. The goal was simple but critical: could this new table-mounted robot safely complete the entire surgery without the surgeon having to stop and switch to traditional methods or open the patient up with a large incision? The researchers also wanted to see how often complications occurred and how the system performed when used by surgeons with varying levels of experience.
The results showed that the new system worked exactly as intended. Every single one of the thirty patients underwent the full gastric bypass procedure using only the robotic arms. No one had to be converted to an open surgery or a standard laparoscopic approach. The median age of the patients was forty-two, and their body mass index, a measure of body fat, averaged 46.7. The surgeries were performed by eleven different surgeons, some of whom had performed hundreds of robotic cases before, while others had less experience with the technology. Despite these differences in skill level and the fact that the operating rooms varied from site to site, the system allowed every surgeon to finish the job. The median time spent operating was 154 minutes, and the average amount of blood lost was only 20 milliliters, which is a very small amount.
Safety was a primary focus of the investigation. Within thirty days of the surgery, five patients experienced complications related to the device or the procedure, a rate of 16.7 percent. This was well below the safety threshold the researchers had set before the study began. The complications included a few specific issues, such as a small tear in the outer layer of the intestine or a minor burn on the bowel surface, but all of these were identified and fixed immediately while the patient was still on the operating table. In one instance, a small hole in the intestine occurred before the robot was even attached, during the initial step of entering the abdomen with a standard tool; this was also repaired without needing to stop the robotic portion of the surgery. Crucially, no patient required a second operation to fix a problem, no leaks occurred at the internal connections, and there were no deaths.
The study also looked at how the new design affected the flow of the operation. Because the robotic arms are mounted on the table itself, the system is more compact and moves with the patient if they need to be repositioned. This design allowed the team to complete all the necessary steps, from creating the new stomach pouch to connecting the intestines, without the need to disconnect and reconnect the robot. The findings suggest that this new architecture is a viable alternative to the older, cart-based systems. The data from this trial was significant enough to support regulatory approval from the U.S. Food and Drug Administration, allowing the system to be used for this specific type of surgery. The study confirms that a robotic system with arms built into the table can handle the complexity of gastric bypass safely and effectively, offering a new option for surgeons and patients alike.
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