The Asensus Paediatric Robotic Registry

NCT07081828 | Recruiting FDA Device

• 1 other identifier: miniTRUST
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Surgery in Early Childhood

Keywords

Robotic; Laparoscopic; Senhance

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  Rate of Adverse Event (Clavien \>3)

  Index surgery to 30 days postoperative

• Procedure-related severe adverse event

  Percent of procedurally related SAE after adjudication

  Index surgery to 30 days post-operative

Secondary Outcomes (5)

• Length of Stay

  From day of index procedure to hospital discharge, up to 2 weeks

• Conversion to unplanned open surgery

  Intraoperative (during index surgical procedure)

• COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age

  Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.

• Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age.

  Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.

• Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age.

  Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.

Interventions

Surgery DEVICE

Patients who undergo surgery utilising the Senhance Surgical System.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \< 18 years of age
• Body weight \> 10 kg
• Indication for a potential robot-assisted operation
• Expected survival of \> 3 months

You may not qualify if:

• 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).

Sponsors & Collaborators

• Asensus Surgical: lead
• RQM+: collaborator

Study Sites (1)

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

München, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Jan Gödeke, Dr. med.

  Dr. von Hauner Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Smith, PhD

CONTACT

608-957-4850; ssmith@asensus.com

Monica Marini

CONTACT

mmarini@asensus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): October 1, 2035
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

DE (1)