Single Port Robotic System for Pediatric Surgery
Official title: Use of the Single Port Robotic System in Pediatric Surgery
Run by Centre Hospitalier Universitaire de Saint Etienne · NCT07660497 · Data updated 2026-11-12
This study tests whether the Single Port robotic system can be safely used to perform certain pediatric abdominal surgeries (like pyeloplasty and reflux procedures) in children aged 1 to 17.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 17 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07660497 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 1 to 17 who need abdominal surgery such as pyeloplasty, vesicoureteral reflux surgery, or gastroesophageal reflux treatment and have consent from guardians.
✕Probably not a fit
Patients who have contraindications to robotic surgery or who require multiple prior abdominal surgeries may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study aims to assess the feasibility of using a single-port robotic platform for pediatric abdominal procedures, including pyeloplasty, ureterovesical reimplantation, and gastroesophageal reflux treatment. It builds on prior robotic approaches by substituting a single access port for multiple trocars, potentially reducing invasiveness. Patients are children and adolescents requiring abdominal surgery at Saint-Etienne University Hospital, with involvement limited to those meeting specific age and consent criteria. Outcomes focus on technical feasibility, safety, and perioperative performance of the single-port system. The trial is conducted under a non-randomized, interventional framework at a single center with a defined lead sponsor.
Why it matters
Potential benefit: If successful, children could experience less surgical trauma and faster recovery with the single-port robotic approach.
How similar studies have gone: Robotic single-port concepts have shown feasibility in adults; pediatric data are limited, making this investigation relatively novel but informed by related robotic approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Chu de Saint-Etienne Hopital Nord
Saint-Etienne, France Recruiting
Study contacts
- Principal investigator: Aurelien Scalabre, PHD — Chu de Saint-Etienne Hopital Nord
- Study coordinator: Aurélien SCALABRE, PHD
- Email: aurelien.scalabre@chu-st-etienne.fr
- Phone: (0)4 77 82 80 37
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.