NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

The Asensus Paediatric Robotic Registry

TerminatedN/A

Sponsor: Asensus Surgical

Conditions: Surgery, Surgery in Early Childhood

Interventions: Surgery

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: — to 17 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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).

Locations (1)

München, Germany