The Asensus Paediatric Robotic Registry

Launched by ASENSUS SURGICAL · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a robotic surgical system called the Senhance Surgical System to help perform certain types of minimally invasive surgeries in children under 18 years old. The goal is to collect information about how well this robotic technology works and how safe it is when used in real surgeries at different hospitals. This trial is currently looking for participants who need or have had surgery that can be assisted by this robotic system.

Children may be eligible if they weigh more than 10 kg (about 22 pounds), are under 18 years old, and are expected to live at least three months after surgery. However, children needing heart surgery or certain chest surgeries, or those with specific medical conditions like cancer or implanted devices that interfere with the robotic tools, cannot take part. Parents who prefer traditional surgery or who do not understand the local or English language may also not be eligible. If a child joins, their surgery will be done with the help of the robotic system, and the doctors will carefully watch and record how the procedure goes to better understand its benefits and risks.

Gender

ALL

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).