Clinical trial NCT06103136: Maestro 1.1 Post-Market Registry
Official title: Maestro 1.1 Post-Market Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Keywords: abdominal laparoscopic surgery
surgical assistance device
Lead sponsor: Moon Surgical
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General population scheduled for laparoscopic surgery.

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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 ]
measure: 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
timeFrame: During procedure
Secondary outcomes:
measure: Incidence of procedure-specific complications
timeFrame: During procedure
measure: Procedure duration
timeFrame: During procedure
measure: Wheels-in Wheels-out
timeFrame: During procedure
measure: Skin to Skin time
timeFrame: During procedure
measure: Recovery time
timeFrame: 30 days
measure: Turnaround time
timeFrame: During Procedure
measure: Camera cleaning rate
timeFrame: During procedure
measure: Post operative pain
timeFrame: 1 day after the procedure
measure: Potential post-operative complications
timeFrame: 30 days
measure: Human resource utilization for surgical assistance in the operating room
timeFrame: During procedure
measure: Surgeon comfort evaluated on 1-5 scale at the end of the procedure
timeFrame: During procedure
measure: Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure
timeFrame: During procedure
measure: Registry device preparation duration
timeFrame: During procedure
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Fort Myers
country: United States
facility: Lee Health
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center Beaches
state: Florida
city: Orlando
country: United States
facility: Orlando Veterans Affairs Medical Center
state: Florida
city: Cedar Park
country: United States
facility: Surgeon's Point ASC
state: Texas
city: Auderghem
country: Belgium
facility: Chirec Delta
city: Mougin
country: France
facility: Hôpital Privé Arnault Tzanck
state: Alpes Maritimes
city: Besançon
country: France
facility: Polyclinique de Franche-Comté
city: Marseille
country: France
facility: Clinique Bouchard
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnault Tzanck
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
Study officials:
References: