The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
Study Type
OBSERVATIONAL
Enrollment
600
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.
Rose Medical Center
Denver, Colorado, United States
RECRUITINGLee Health
Fort Myers, Florida, United States
RECRUITINGAdverse 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: 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
Time frame: During procedure
Incidence of procedure-specific complications
Time frame: During procedure
Procedure duration
Time frame: During procedure
Wheels-in Wheels-out
Timing and durations of Maestro's use in the procedure
Time frame: During procedure
Skin to Skin time
Duration between the first incision and the last suture
Time frame: During procedure
Recovery time
Assess whether the patient has fully recovered after 30 days
Time frame: 30 days
Turnaround time
Time between the start of two interventions compared to a baseline without the use of the Maestro System
Time frame: During Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baptist Health
Jacksonville, Florida, United States
RECRUITINGBaptist Medical Center Beaches
Jacksonville, Florida, United States
RECRUITINGOrlando Veterans Affairs Medical Center
Orlando, Florida, United States
RECRUITINGSurgeon's Point ASC
Cedar Park, Texas, United States
RECRUITINGChirec Delta
Auderghem, Belgium
RECRUITINGHôpital Privé Arnault Tzanck
Mougin, Alpes Maritimes, France
RECRUITINGPolyclinique de Franche-Comté
Besançon, France
RECRUITINGClinique Bouchard
Marseille, France
RECRUITING...and 2 more locations
Camera cleaning rate
the rate at which the surgeon extracts the endoscope from the patient to clean it
Time frame: During procedure
Post operative pain
Visual analogue scale 0 - no pain to 10 - worst pain possible
Time frame: 1 day after the procedure
Potential post-operative complications
Time frame: 30 days
Human resource utilization for surgical assistance in the operating room
Number and type of staff in the OR during the procedure
Time frame: During procedure
Surgeon comfort evaluated on 1-5 scale at the end of the procedure
1 - not comfortable 5 - very comfortable
Time frame: During procedure
Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure
1 - not satisfied 5 - very satisfied
Time frame: During procedure
Registry device preparation duration
Time frame: During procedure