Post-Market Clinical Study to Evaluate the Versius Surgical System

Purpose of Study

What is the Purpose of this Study?

The purpose of this study is to collect information about the performance of the Versius Surgical System for gallbladder removal (cholecystectomy) surgery. Participants will be patients whose doctor plans to perform gallbladder removal surgery using Versius. Gallbladder removal with the aid of a robotic system like Versius is a standard surgery; the Versius Surgical System is not experimental and has been approved by the U.S. Food and Drug Administration (FDA). Versius is a robot controlled by the surgeon that is designed to be used in “keyhole surgery" (surgery done through a few small cuts in the skin instead of one large cut). Versius consists of a set of robotic arms. One of the arms has a camera and light source, while the other arms have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them while seeing the surgical area on a screen. Study procedures include collection of demographic information, medical history, details on the surgical process, patient’s health, and recovery after surgery.


Study Eligibility

Eligibility


  • * 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
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Study Sites

Where can I participate?



Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Other

Principal Investigator
1

Burch, Miguel

Age Group

Adult

Phase

N/A

IRB Number

STUDY00004462

ClinicalTrials.gov ID

NCT07096856

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Email

clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Burch, Miguel

Age Group

Adult

Phase

N/A

IRB Number

CA-00583

ClinicalTrials.gov ID

NCT07096856

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org