Cholecystectomy, RoboticNCT07096856
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
A study testing Robotic assisted cholecystectomy in people with Cholecystectomy, Robotic, run by CMR Surgical Ltd at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cholecystectomy, Robotic
- What is being tested?
- Robotic assisted cholecystectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Mar 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Erik Wilson, 713-500-7277, erik.b.wilson@uth.tmc.edu
- Recruiting
Cedar-Sinai Heatlh Sciences University
Los Angeles, California, 90048
Miguel Burch, 310-423-8350, Miguel.Burch@csmc.edu
- Recruiting
University of California San Diego Health
San Diego, California, 92037
Ryan Broderick, 858-657-8860, rbroderick@health.ucsd.edu
About this study
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?
Read more
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
- Being tested
- Robotic assisted cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted cholecystectomyDevice
Robotic assisted cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Cholecystectomy Using the Versius Surgical System | Experimental | Not described Receives: Device: Robotic assisted cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From end of surgery through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start23 Mar 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, RoboticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Broderick, Principal investigator, University of California San Diego HealthMiguel Burch, Principal investigator, Cedars-Sinai Health Sciences UniversityErik Wilson, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096856
- Sponsor's protocol ID
- CA-00583
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
- ClinicalTrials.gov ID
- NCT07096856
- Acronym / sponsor ID
- CA-00583
- Conditions
- Cholecystectomy, Robotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Cholecystectomy Using the Versius Surgical System | Experimental | Device: Robotic assisted cholecystectomy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic assisted cholecystectomyRobotic assisted cholecystectomy | Device | Robotic-Assisted Cholecystectomy Using the Versius Surgical System |
Primary outcome
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 successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
Rate of serious adverse events up to 30 days post procedure.
Time frame: From end of surgery through 30 days post-procedure
Rate of serious adverse events up to 30 days post procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Broderick principal investigator
University of California San Diego Health
Miguel Burch principal investigator
Cedars-Sinai Health Sciences University
Erik Wilson principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted cholecystectomy in people with Cholecystectomy, Robotic, run by CMR Surgical Ltd at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morad Nakleh (+44 7746008535, morad.naklheh@cmrsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.