Asensus paediatric robotic registry for laparoscopic surgery

The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery

This registry collects information on children having laparoscopic surgery with the Senhance robotic system to see how safe it is and how they recover.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: Asensus Surgical (industry)
• Locations: 1 site (München)
• Trial ID: NCT07081828 on ClinicalTrials.gov

What this trial studies

This is a prospective and retrospective, multi-center, observational registry collecting clinical and procedural data on pediatric patients who have undergone or will undergo laparoscopically-assisted surgery using the Senhance Surgical System. The registry is open-label and pulls both historical chart data and prospective follow-up information to capture safety events, length of hospital stay, procedural details, and patient-reported outcomes. Enrolled subjects are children under 18 years weighing more than 10 kg who are candidates for a robot-assisted laparoscopic approach, with exclusions for cardiac/major-vessel or certain thoracic procedures and other contraindications. The primary focus is on safety outcomes while secondary endpoints address recovery metrics and procedural performance.

Who should consider this trial

Good fit: Children under 18 years old who weigh more than 10 kg, have an indication for a laparoscopically-assisted procedure where the Senhance system can be used, and have an expected survival over three months are ideal candidates.

Not a fit: Patients requiring cardiac or major-vessel surgery, certain thoracic or upper mediastinal procedures, those with electrosurgery contraindications or relevant implants, pregnant patients beyond the second trimester, or those unsuitable for laparoscopy are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the registry could improve understanding of the safety and recovery profile of Senhance-assisted pediatric laparoscopy and guide safer, more informed use.

How similar studies have performed: Other robotic platforms (for example the da Vinci system) have shown feasibility and safety in many pediatric laparoscopic procedures, but published evidence specific to the Senhance system in children remains limited.

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).

Where this trial is running

München

• Dr. von Hauner Children's Hospital Clinic of the University of Munich — München, Germany (RECRUITING)

Study contacts

• Principal investigator: Jan Gödeke, Dr. med. — Dr. von Hauner Children's Hospital
• Study coordinator: Stephanie Smith, PhD

Conditions: Surgery, Surgery in Early Childhood, Robotic, Laparoscopic, Senhance