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

NCT07096856 | Not Yet Recruiting FDA Device

• 1 other identifier: CA-00583
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery

  Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery

  From start of surgery to end of procedure

• Rate of serious adverse events up to 30 days post procedure.

  Rate of serious adverse events up to 30 days post procedure.

  From end of surgery through 30 days post-procedure

Study Arms (1)

Robotic-Assisted Cholecystectomy Using the Versius Surgical System

EXPERIMENTAL

Device: Robotic assisted cholecystectomy

Interventions

Robotic assisted cholecystectomy DEVICE

Robotic assisted cholecystectomy

Robotic-Assisted Cholecystectomy Using the Versius Surgical System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy 2. Patients providing written informed consent to participate in the study

You may not qualify if:

• Patient unwilling to provide informed consent
• Patients undergoing surgery or treatment for malignant disease
• Patients undergoing a concomitant surgical procedure
• Medical contraindication for general anaesthesia or minimally invasive procedure
• Contraindication for undergoing surgery with Versius (Bleeding diathesis, Active pregnancy or BMI ≥40 kg/m2)

Sponsors & Collaborators

• CMR Surgical Ltd: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07