NCT07096856

Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CMR Surgical Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults. The main questions it aims to answer are: How often can the surgery be successfully completed using Versius without needing to switch to a different surgical method? What serious complications, if any, occur within 30 days after surgery? Researchers will collect information from adult patients who have gallbladder surgery using the Versius system in U.S. hospitals. The purpose is to better understand how the device performs and how patients recover after surgery. Participants will: Be adults age 22 or older who are eligible for minimally invasive gallbladder surgery Undergo robotic-assisted surgery using the Versius Surgical System Allow the research team to collect data during surgery and up to 30 days after Complete standard follow-up visits after discharge Patients with certain medical conditions, such as cancer, high BMI (≥40 kg/m²), or contraindications to anesthesia or robotic surgery, will not be included in the study. This study is sponsored by CMR Surgical Ltd., the manufacturer of the Versius system.

Conditions

• Cholecystectomy, Robotic

Interventions

Type	Name	Description
DEVICE	Robotic assisted cholecystectomy	Robotic assisted cholecystectomy

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Regulatory

• FDA-regulated device study