NCT07081828

The Asensus Paediatric Robotic Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Asensus Surgical · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Surgery
• Surgery in Early Childhood

Interventions

Type	Name	Description
DEVICE	Surgery	Patients who undergo surgery utilising the Senhance Surgical System.

Timeline

• Start date: 2025-06-17
• Primary completion: 2035-07-01
• Completion: 2035-10-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study