Maestro 1.0 Post-Market Registry

Study Overview
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Brief Summary
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The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

Official Title
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Maestro 1.0 Post-Market Registry

Conditions
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Surgery

Intervention / Treatment
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* Device: Laparoscopic surgery using the Maestro Platform


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients operated using the Maestro platform<br> | Device: Laparoscopic surgery using the Maestro Platform<br>* 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.<br>|
| Control<br> | Device: Laparoscopic surgery using the Maestro Platform<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-specific complications |  | During procedure | 
| Procedure duration |  | During procedure | 
| Wheels-in Wheels-out | Timing and durations of Maestro's use in the procedure | During procedure | 
| Skin to Skin time | Duration between the first incision and the last suture | During procedure | 
| Recovery time | Assess whether the patient has fully recovered after 30 days | 30 days | 
| Turnaround time | Time between the start of two interventions compared to a baseline without the use of the Maestro System | During Procedure | 
| Camera cleaning rate | the rate at which the surgeon extracts the endoscope from the patient to clean it | During procedure | 
| Post operative pain | Visual analogue scale 0 - no pain to 10 - worst pain possible | 1 day after the procedure | 
| Potential post-operative complications |  | 30 days | 
| Human resource utilization for surgical assistance in the operating room | Number and type of staff in the OR during the procedure | During procedure | 
| Surgeon comfort evaluated on 1-5 scale at the end of the procedure | 1 - not comfortable 5 - very comfortable | During procedure | 
| Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure | 1 - not satisfied 5 - very satisfied | During procedure | 
| Registry device preparation duration |  | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal laparoscopic surgery, surgical assistance device