Versius Surgical System
DeviceUrological minimal access surgery performed with Versius Surgical System
Recruiting
NCT Number: NCT06539442
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device) in Urological Procedures in Paediatric population. In alignment with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework, this study will consist of 3 main phases to ensure proper procedure development while ensuring patients safety. Feasibility and safety will be assessed on an ongoing basis, and specifically after completion of the first 3 procedures, at a single site (Southampton/Lead), each conducted one week apart to allow the identification of unanticipated risks/adverse events. Once deemed safe, based on the results of the 3 cases enrolled in Phase I, 7 further cases would be completed, at the same site. Once the procedure is deemed safe according to safety data collected, the recruitment will proceed to full trial patient accrual, 140 additional cases from the 3 participating study sites.The study patient population is children and adolescents under the age of 18, which will be provided clinical care and follow-ups per standard of care and hospital's policy.
Recruiting
Interested in participating?
Request InfoKey information
Age range
0 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Department of Paediatric Urology, Evelina London Children's Hospital, London, United Kingdom
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients, male or female, (<18 years old) for whom an appropriate legal representative provides written consent for participation
- Patient and disease factors deemed suitable for minimal access urological procedure
- Multidisciplinary team (MDT) decision to treat with surgery
- Patients under the care of the paediatric urology team in one of the participating centres
Exclusion criteria
- Patients ≥ 18 years old
- Appropriate legal representative unwilling to provide written consent
- Medical contraindication for general anaesthesia
- Medical contraindication for laparoscopic procedure
- Active pregnancy (in post-pubertal female patients)
- Morbid obesity (BMI ≥ 40 kg/m2)
- Patient participation in an interventional clinical study, that could impact primary objectives results
- Prior pelvic /abdominal radiotherapy treatment
- Subjects with other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure
Treatment and study plan
Primary outcomes
-
Adverse Event rate
Time frame: Up to 3 months post operation
Incidence of adverse events
Secondary outcomes
-
Procedure completion
Time frame: Day of operation
Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery
-
Serious Adverse Event Rate
Time frame: Up to 3 months post-operation
Incidence of serious adverse events
-
Ultrasound grading
Time frame: 3 months post stent removal
Ultrasound hydronephrosis grading results
-
MAG3 Renogram
Time frame: 3 months post stent removal
MAG3 Renogram results
-
Operative time
Time frame: Day of operation
Surgery duration from skin incision to skin closure in minutes
-
Blood loss
Time frame: Day of operation
Estimated blood loss in mL
-
Post operative analgesic treatment
Time frame: Immediately after surgery
Pain medication prescribed post-operatively
-
Length of stay
Time frame: Up to 3 months post operation, average 1 day
Hospital stay from end of surgery to discharge in days
-
Reoperation
Time frame: 24 hours post operation
Reoperation within 24 hours of surgery
-
Unplanned readmission
Time frame: Up to 3 months post operation
Unplanned hospital readmissions
-
Device deficiencies and user errors
Time frame: Day of operation
Device deficiencies and user errors that occur during surgery
-
Ultrasound grading
Time frame: 12 months post operation
Ultrasound hydronephrosis grading results
Study contacts
Contact information is provided by the study sponsor or research team.
Mark Slack, MD
CONTACT
Morad Nakhleh, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
CMR Surgical Ltd
Industry
Collaborators
- University Hospital Southampton NHS Foundation Trust
Registry information
Official study title
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Aug 6, 2024
- Registry last updated
- Oct 15, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.