Maestro 1.1 Post-Market Registry
ConditionSurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMoon Surgical
About this trial
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.
Disqualifiers
Participants might be excluded based on the investigator's discretion.
Trial population
General population scheduled for laparoscopic surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic surgery using the Maestro Platform
DevicePatients 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Patients operated using the Maestro platform1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
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
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 ]2
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 procedureSecondary outcomes
1
Incidence of procedure-specific complications
Time frame
During procedure2
Procedure duration
Time frame
During procedure3
Wheels-in Wheels-out
Timing and durations of Maestro's use in the procedure
Time frame
During procedure4
Skin to Skin time
Duration between the first incision and the last suture
Time frame
During procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov