The Asensus Paediatric Robotic Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery.
- Who it may be relevant to
- Registry conditions: Surgery, Surgery in Early Childhood. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery
Overview
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
Detailed description
This is a prospective and retrospective, multi-center, observational registry study evaluating the use of the Senhance Surgical System in paediatric patients undergoing laparoscopically-assisted surgery. The trial is open-label and designed to collect both historical and prospective data from participating centers. Paediatric subjects who have undergone or will undergo procedures with the Senhance Surgical System will be enrolled. The primary purpose for this study is to assess safety outcomes. Secondary endpoints include length of hospital stay, procedural information, and patient-reported outcomes.
Interventions
- Device Surgery
Patients who undergo surgery utilising the Senhance Surgical System.
Primary outcome measures
- Adverse Event [Time frame: Index surgery to 30 days postoperative]
- Procedure-related severe adverse event [Time frame: Index surgery to 30 days post-operative]
Secondary outcome measures (5)
- Length of Stay [Time frame: From day of index procedure to hospital discharge, up to 2 weeks]
- Conversion to unplanned open surgery [Time frame: Intraoperative (during index surgical procedure)]
- COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age [Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]
- Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age. [Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]
- Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age. [Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.]
Eligibility criteria
Inclusion criteria
- < 18 years of age
- Body weight > 10 kg
- Indication for a potential robot-assisted operation
- Expected survival of > 3 months
Exclusion criteria
- Subjects requiring surgery on the heart or greater vessels.
- Subjects for whom a laparoscopic approach and endoscopic approach in the thoracic area is not appropriate.
- Anaesthetic contraindications, children with pacemakers or other implants for which electrosurgery must be avoided, children with cancer, parents who prefer to proceed with classical or manual laparoscopic surgery.
- Subjects pregnant over the second trimester of pregnancy.
- Parents or children with insufficient understanding of the site's local language (e.g. Dutch, German) or English language.
- Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters due to which an endoscopic or laparoscopic surgical technique is contraindicated.
- Subjects who would require an intervention to the upper mediastinum or to the upper pleural cavity regions as referred in the Senhance Surgical System User Manual (UM-001-00035\_CE).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Dr. von Hauner Children's Hospital Clinic of the University of Munich — München
Publications
- Killaars REM, Visschers RGJ, Cakir H, Dinjens DJA, Widmann DL, Friedrich H, Muensterer O, van Gemert WG, Goedeke J; MiniTrust Collaborative Study Group. Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study). BMJ Open. 2026 Mar 26;16(3):e110106. doi: 10.1136/bmjopen-2025-110106. PMID 41887639
Identifiers
NCT: NCT07081828 · miniTRUST