Recruiting NCT06103136
Maestro 1.1 Post-Market Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic surgery using the Maestro Platform.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
Interventions
- Device Laparoscopic surgery using the Maestro Platform
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
Primary outcome measures
- 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 ]]
- 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]
Secondary outcome measures (12)
- Incidence of procedure-specific complications [Time frame: During procedure]
- Procedure duration [Time frame: During procedure]
- Wheels-in Wheels-out [Time frame: During procedure]
- Skin to Skin time [Time frame: During procedure]
- Recovery time [Time frame: 30 days]
- Turnaround time [Time frame: During Procedure]
- Camera cleaning rate [Time frame: During procedure]
- Post operative pain [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 [Time frame: During procedure]
- Surgeon comfort evaluated on 1-5 scale at the end of the procedure [Time frame: During procedure]
- Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure [Time frame: During procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Rose Medical Center — Denver
- Lee Health — Fort Myers
- Baptist Health — Jacksonville
- Baptist Medical Center Beaches — Jacksonville
- Orlando Veterans Affairs Medical Center — Orlando
- Surgeon's Point ASC — Cedar Park
France · 5 centers
- Hôpital Privé Arnault Tzanck — Mougin
- Polyclinique de Franche-Comté — Besançon
- Clinique Bouchard — Marseille
- Institut Arnault Tzanck — Saint-Laurent-du-Var
- Clinique de l'Orangerie — Strasbourg
Belgium · 1 center
- Chirec Delta — Auderghem
Identifiers
NCT: NCT06103136 · Maestro1.1 PostMarket Registry