The Asensus Paediatric Robotic Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAsensus Surgical
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
< 18 years of age
Body weight > 10 kg
Indication for a potential robot-assisted operation
Expected survival of > 3 months
Disqualifiers
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.
Trial population
Paediatric patients at a participating center who have had or are scheduled to have surgery using the Senhance system
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgery
DevicePatients who undergo surgery utilising the Senhance Surgical System.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Adverse Event
Rate of Adverse Event (Clavien \>3)
Time frame
Index surgery to 30 days postoperative2
Procedure-related severe adverse event
Percent of procedurally related SAE after adjudication
Time frame
Index surgery to 30 days post-operativeSecondary outcomes
1
Length of Stay
Total duration (in days) of hospitalization related to the index surgical procedure
Time frame
From day of index procedure to hospital discharge, up to 2 weeks2
Conversion to unplanned open surgery
Rate of unplanned conversions from laparoscopic to open surgery.
Time frame
Intraoperative (during index surgical procedure)3
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.
Time frame
Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.4
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.
Time frame
Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Asensus Surgical
Lead sponsor
RQM+
Collaborator
Source ClinicalTrials.gov