The Asensus Paediatric Robotic Registry (miniTRUST)

Asensus Surgical

Status: Enrolling

Conditions: Surgery in Early Childhood; Surgery

Treatments: Device: Surgery

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07081828

miniTRUST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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).