The Asensus Paediatric Robotic Registry (miniTRUST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Surgery in Early Childhood
• Intervention / Treatment: Device: Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stephanie Smith, PhD; Phone Number: 608-957-4850; Email: ssmith@asensus.com
• Study Contact Backup: Name: Monica Marini; Email: mmarini@asensus.com

Study Locations

• Germany
  • München, Germany
    • Recruiting
    • Dr. von Hauner Children's Hospital Clinic of the University of Munich
    • Contact: Jan Gödeke, MD, MBA; Phone Number: +49 89 4400 53101; Email: jan.goedeke@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Total duration (in days) of hospitalization related to the index surgical procedure	From day of index procedure to hospital discharge, up to 2 weeks
Conversion to unplanned open surgery	Rate of unplanned conversions from laparoscopic to 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	The COMFORT-B Score is a validated behavioral assessment tool designed to evaluate the level of sedation, pain, and distress in pediatric patients. The COMFORT-B scale will be used to assess pain levels in children aged 0 to less than 2 years of age. The COMFORT-B scale includes six behavioral dimensions: Alertness, Calmness/Agitation, Respiratory Response (only in mechanically ventilated children), Crying (only in spontaneously breathing children), Physical Movement, Muscle Tone, and Facial Tension. Each dimension is scored on a scale from 1 to 5, yielding a total score range of 6 to 30. Higher scores indicate greater distress or discomfort.	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.	The FLACC scale assesses pain by observing five categories of behaviors and assigning a score of 0-2 to each category, resulting in a total score of 0-10, where a score of 10 indicates a higher level of pain. The following five behavioral categories are assessed: Facial expression, leg movement, Activity level, Crying, and Consolability. The FLACC scale will be utilized to assess pain in children aged 2 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.	Pain will be assessed using a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain). The NRS scale will be used for 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.

Collaborators and Investigators

• Sponsor: Asensus Surgical
• Collaborators: RQMplus
• Investigators: Principal Investigator: Jan Gödeke, Dr. med., Dr. von Hauner Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): October 1, 2035

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic; Robotic; Senhance
• Other Study ID Numbers: miniTRUST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No