The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Asensus Surgical
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Adverse Event
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Adverse Event
Time Frame: Index surgery to 30 days postoperative
Rate of Adverse Event (Clavien \>3)
Procedure-related severe adverse event
Time Frame: Index surgery to 30 days post-operative
Percent of procedurally related SAE after adjudication
Secondary Outcomes
- 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.)
- 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.)
- Length of Stay(From day of index procedure to hospital discharge, 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.)