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Can robots make pediatric surgery safer? a new registry aims to find out

NCT ID NCT07081828

Knowledge-focused Sponsor: Asensus Surgical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study is a registry that collects data on children under 18 who undergo robot-assisted laparoscopic surgery using the Senhance Surgical System. The goal is to track safety and outcomes, such as complications, hospital stay length, and pain levels. By gathering real-world information, researchers hope to better understand how this technology performs in pediatric patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Senhance Surgical System (robot-assisted laparoscopic surgery)
What this could lead to
If successful, this registry could help establish the safety and feasibility of robot-assisted surgery in children, potentially expanding its use in pediatric care.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the robot is better than standard surgery. It only tracks outcomes in a small group of children, and results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

37 people

The number who actually took part.

Started

Jun 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Paediatric patients at a participating center who have had or are scheduled to have surgery using the Senhance system

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgery Surgery in early childhood

Contacts and locations

Locations

  • Dr. von Hauner Children's Hospital Clinic of the University of Munich

    München, Germany

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