Use of the Single Port Robotic System in Pediatric Surgery (NCT07660497) | Clinical Trial Compass
RecruitingNot Applicable
Use of the Single Port Robotic System in Pediatric Surgery
France10 participantsStarted 2025-11-14
Plain-language summary
Open surgery (laparotomy) has long been the gold standard for pediatric surgery. The development of laparoscopy in the 1980s reduced post-operative pain. Since the 2000s, robotic surgery has been on the rise. The most commonly used robotic system is the Xi robotic system (Intuitive Surgical), which allows instruments to be inserted through three or four trocars and replicates the movements of the surgeon's hands as they sit at a control console a few meters away from the patient.The Single Port (SP) robotic system is a new development in this technology. It allows the same procedures to be performed using a single trocar instead of four. CE marking was obtained in 2024 for abdominal surgery, but without provision for use in children. The pediatric surgery team at Saint-Etienne University Hospital has been performing robotic surgery using the Xi (Intuitive) system since January 2020. Between January 2020 and April 2025, 150 patients underwent surgery, including 49 pyeloplasties, 42 ureterovesical reimplantations, and 23 gastroesophageal reflux treatments. No conversions were necessary, and there were no complications related to the use of the robotic system. The Saint-Etienne University Hospital was the first institution in France to acquire the SP robotic system.
Who can participate
Age range
1 Year – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 10 and 17 inclusive for the first five and between 1 and 17 for the next five
* Parents or guardians affiliated with or entitled to social security
* Patient and legal representative of the patient who has received informed information about the study and has signed the consent form for the child's participation in the study.
* Patients seen in paediatric surgery consultations at Saint-Etienne University Hospital
* Patient requiring abdominal surgery such as pyeloplasty, vesicoureteral reflux or gastro-oesophageal reflux
Exclusion Criteria:
* History of haemorrhagic disease
* History of multiple abdominal surgeries (as intraperitoneal adhesions can make surgical access difficult)
* Pregnant adolescents
* Patients with electronic implants (e.g. pacemakers).
* Parents or guardians under guardianship or trusteeship.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conversion use
Timeframe: Day 1 : surgery day
2
Duration of surgery under general anesthesia
Timeframe: Day 1 : surgery day
3
Complications related to the use of the SP robotic system
Timeframe: Day 1 : surgery day
Trial details
NCT IDNCT07660497
SponsorCentre Hospitalier Universitaire de Saint Etienne