Recruiting

Versius

Sponsor:

CMR Surgical Ltd

Code:

NCT07096856

Conditions

Cholecystectomy, Robotic

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Robotic assisted cholecystectomy

Study Details

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

Study ID

NCT07096856

Start date

Mar 23, 2026

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1\. 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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic-Assisted Cholecystectomy Using the Versius Surgical System

Interventions

Robotic assisted cholecystectomy

Robotic assisted cholecystectomy

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 ]
  • Rate of serious adverse events up to 30 days post procedure. [ Time Frame: From end of surgery through 30 days post-procedure ]

Central Contacts and Locations

Central contacts

Morad Nakleh

+44 7746008535morad.naklheh@cmrsurgical.com

Martin Ramette

+447761631263martin.ramette@cmrsurgical.com

Locations

Cedar-Sinai Heatlh Sciences University

Recruiting

Los Angeles, California, United States, 90048

Contacts

Miguel Burch

310-423-8350Miguel.Burch@csmc.edu

University of California San Diego Health

Recruiting

San Diego, California, United States, 92037

Contacts

Ryan Broderick

858-657-8860rbroderick@health.ucsd.edu

More Information

Sponsor

CMR Surgical Ltd

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by CMR Surgical Ltd on 2026-09-11.