The Asensus Paediatric Robotic Registry
Recruiting now
Conditions studied: Surgery, Surgery in Early Childhood
In brief
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.
Key facts
- Study ID
- NCT07081828
- Run by
- Asensus Surgical
- People needed
- 1000
- Starts
- 2025-06-17
- Expected to finish
- 2035-10-01
- Last updated by the study team
- 2025-07-23
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- < 18 years of age
- Body weight > 10 kg
- Indication for a potential robot-assisted operation
- Expected survival of > 3 months
You may not qualify if…
- 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).
Where it is running
- Dr. von Hauner Children's Hospital Clinic of the University of Munich — München, Germany (enrolling)
Full record on ClinicalTrials.gov
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