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The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure using the Maestro Platform | Experimental | Study participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic surgery using the Maestro Platform | Device | Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform. |
| 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 | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedure-specific complications | During procedure | |
| Procedure duration | During procedure | |
| Recovery time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy-Bernard CADIERE, Pr | CHU Saint-Pierre, Brussels, Belgique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Brussels | Belgium |
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| 30 days |
| Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible) | 1 day after procedure |
| Number of rehospitalization per patient within 30 days | 30 days |
| Number of repeat surgery or reintervention per patient within 30 days | 30 days |
| Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable) | During procedure |
| Surgeon satisfaction with the level of assistance provided by the Maestro platform, on 1-10 scale at the end of the procedure (1-assistance much worse than a human assistant, 5-equivalent to human assistant, 10-much better than human assistant) | During procedure |
| Study device usability on 1-10 scale at the end of the procedure (1-very hard to use, 5-not difficult but not easy, 10-very easy to use) | During procedure |