Robotic SystemSPCHIRPEDNCT07660497
Use of the Single Port Robotic System in Pediatric Surgery
A study testing Singleport robotic system to treat minors in people with Robotic System and Pediatric, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Robotic System, Pediatric, Surgery in Children
- What is being tested?
- Singleport robotic system to treat minors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu de Saint-Etienne Hopital Nord
Saint-Etienne, 42055
AURELIEN SCALABRE, PHD, (0)4 77 82 80 37 ext. +33, aurelien.scalabre@chu-st-etienne.fr
About this study
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.
Read the detailed description
The main objective of this study is to evaluate the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Single Port robotic system to treat minors.
- Conditions
- Robotic System, Pediatric, Surgery in Children
- Being tested
- Singleport robotic system to treat minors
- Keywords
- Single Port Robotic System, Pediatric surgery, Access Port
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singleport robotic system to treat minorsProcedure or surgery
Robotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors.
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery procedures on minors | Experimental | Robotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors. Receives: Procedure: Singleport robotic system to treat minors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion use
A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.
Measured: Day 1 : surgery day
Duration of surgery under general anesthesia
Excessive operating time : over 7 hours
Measured: Day 1 : surgery day
Complications related to the use of the SP robotic system
Any digestive or vascular wound or organ damage caused by a conflict between instruments, or by a technical difficulty in handling the instruments, or occurring during the installation of the system or during the introduction of surgical instruments into the abdominal cavity will be considered a complication related to the use of the SP robotic system.
Measured: Day 1 : surgery day
Secondary outcomes (3)
Operating time estimation
Estimate the operating time in minutes
Measured: Day 1 : surgery day
"console time" estimation
Estimate the "console time" in minutes
Measured: Day 1 : surgery day
Consumption of level III pain medication assessment
Assessment of the amount of painkillers taken post-operatively
Measured: From 4 at 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start14 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SystemStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm study following Simon's two-stage plan. This is a preliminary descriptive study aimed at demonstrating the feasibility of a new surgical technique.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelien Scalabre, PHD, Principal investigator, CHU DE SAINT-ETIENNE HOPITAL NORD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660497
- Sponsor's protocol ID
- 25CH168
- Other IDs
- ANSM
- Acronym
- SPCHIRPED
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Single Port Robotic System in Pediatric Surgery
- ClinicalTrials.gov ID
- NCT07660497
- Acronym / sponsor ID
- SPCHIRPED / 25CH168
- Conditions
- Robotic System, Pediatric, Surgery in Children
- Keywords
- Single Port Robotic System, Pediatric surgery, Access Port
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of this study is to evaluate the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Single Port robotic system to treat minors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm study following Simon's two-stage plan. This is a preliminary descriptive study aimed at demonstrating the feasibility of a new surgical technique.
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery procedures on minors | Experimental | Procedure: Singleport robotic system to treat minorsRobotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singleport robotic system to treat minorsRobotic surgery on minors to assess the feasibility of robotic surgery (pyeloplasty, ureterovesical reimplantation, treatment of gastroesophageal reflux) using the new Singleport robotic system to treat minors. | Procedure or surgery | Robotic surgery procedures on minors |
Primary outcome
Conversion use
Time frame: Day 1 : surgery day
A conversion refers to discontinuing use of the SinglePort robotic system to complete the procedure using another surgical technique.
Duration of surgery under general anesthesia
Time frame: Day 1 : surgery day
Excessive operating time : over 7 hours
Complications related to the use of the SP robotic system
Time frame: Day 1 : surgery day
Any digestive or vascular wound or organ damage caused by a conflict between instruments, or by a technical difficulty in handling the instruments, or occurring during the installation of the system or during the introduction of surgical instruments into the abdominal cavity will be considered a complication related to the use of the SP robotic system.
3 secondary outcomes
Operating time estimation
Time frame: Day 1 : surgery day
"console time" estimation
Time frame: Day 1 : surgery day
Consumption of level III pain medication assessment
Time frame: From 4 at 6 weeks post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurelien Scalabre, PHD principal investigator
CHU DE SAINT-ETIENNE HOPITAL NORD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singleport robotic system to treat minors in people with Robotic System and Pediatric, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélien SCALABRE, PHD ((0)4 77 82 80 37 ext. +33, aurelien.scalabre@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion use (time frame: Day 1 : surgery day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.