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

Conditions

• Cholecystectomy, Robotic

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Robotic assisted cholecystectomy — DEVICE
  Robotic assisted cholecystectomy

Study Details

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.

Key Dates

First listed

Jul 31, 2025

Start date

Mar 23, 2026

Status verified

Sep 2026

Primary completion

Mar 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Robotic-Assisted Cholecystectomy Using the Versius Surgical System

Primary Outcome Measure

Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery [ Time Frame: From start of surgery to end of procedure ]

Central Contacts

• Morad Nakleh
  +44 7746008535
  [email protected]
• Martin Ramette
  +447761631263
  [email protected]

Locations (3)

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