Surgery
Conditions
Keywords
abdominal laparoscopic surgery, surgical assistance device
Brief summary
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
Interventions
Patients scheduled for laparoscopic surgery will be operated on as per standard of care, using standard port, surgical table and instrument placements (following local applicable guidelines), and off-the-shelf surgical equipment. Standard of care surgical technique following local applicable guidelines will be used. The Maestro Platform may be used to position and hold the scope as well as the retractor in the locations determined by the surgeon during the procedure, with the ability to revert at any time to standard of care (manual minimally invasive surgery) without the usage of the Maestro Platform, or to convert to open surgery.
Sponsors
Moon Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.
Exclusion criteria
* Participants might be excluded based on the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications | Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: 30 days ] |
| Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction | During procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wheels-in Wheels-out | During procedure | Timing and durations of Maestro's use in the procedure |
| Skin to Skin time | During procedure | Duration between the first incision and the last suture |
| Recovery time | 30 days | Assess whether the patient has fully recovered after 30 days |
| Turnaround time | During Procedure | Time between the start of two interventions compared to a baseline without the use of the Maestro System |
| Camera cleaning rate | During procedure | the rate at which the surgeon extracts the endoscope from the patient to clean it |
| Incidence of procedure-specific complications | During procedure | — |
| Potential post-operative complications | 30 days | — |
| Human resource utilization for surgical assistance in the operating room | During procedure | Number and type of staff in the OR during the procedure |
| Surgeon comfort evaluated on 1-5 scale at the end of the procedure | During procedure | 1 - not comfortable 5 - very comfortable |
| Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure | During procedure | 1 - not satisfied 5 - very satisfied |
| Registry device preparation duration | During procedure | — |
| Post operative pain | 1 day after the procedure | Visual analogue scale 0 - no pain to 10 - worst pain possible |
| Procedure duration | During procedure | — |
Countries
Belgium, France, United States
Contacts
Primary ContactAnne Osdoit
Outcome results
None listed