Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 11:06 AM
Study NCT ID:
NCT07096856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
Sponsor:
CMR Surgical Ltd
Organization:
Study Overview
Official Title:
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: