The Asensus Paediatric Robotic Registry (NCT07081828) | Clinical Trial Compass
RecruitingNot Applicable
The Asensus Paediatric Robotic Registry
Germany1,000 participantsStarted 2025-06-17
Plain-language summary
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.
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Adverse Event
Timeframe: Index surgery to 30 days postoperative
2
Procedure-related severe adverse event
Timeframe: Index surgery to 30 days post-operative