Maestro 1.1 Post-Market Registry

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

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: Laparoscopic surgery using the Maestro Platform

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Anne Osdoit; Phone Number: +33 6 60 42 28 31; Email: aosdoit@moonsurgical.com

Study Locations

• Belgium
  • Auderghem, Belgium, 1160
    • Recruiting
    • Chirec Delta
    • Contact: Anne Catherine Dandrifosse
• France
  • Besançon, France, 25000
    • Recruiting
    • Polyclinique de Franche-Comté
    • Contact: Henry Mercoli, Dr.
  • Marseille, France
    • Recruiting
    • Clinique Bouchard
    • Contact: Marius Nedelcu, Dr.
  • Saint-Laurent-du-Var, France, 06700
    • Recruiting
    • Institut Arnault Tzanck
    • Contact: Benjamin Cadière, Dr.
  • Strasbourg, France
    • Recruiting
    • Clinique de l'Orangerie
    • Contact: Yannis Mesli, Dr
  • Alpes Maritimes
    • Mougin, Alpes Maritimes, France, 06250
      • Recruiting
      • Hopital prive Arnault Tzanck
      • Contact: Eugenio Benvenuto, Dr.
• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • Recruiting
      • Rose Medical Center
      • Contact: Michael Snyder, MD, FACS
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Recruiting
      • Lee Health
      • Contact: Thomas Bass, MD, FACS
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health
      • Contact: Steven Hodgett
    • Jacksonville, Florida, United States, 32250
      • Recruiting
      • Baptist Medical Center Beaches
      • Contact: Thomas Austgen, MD, FACS
    • Orlando, Florida, United States, 32827-5812
      • Recruiting
      • Orlando Veterans Affairs Medical Center
      • Contact: Jessica Feranec, MD, FACOG
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Recruiting
      • Surgeon's Point ASC
      • Contact: Eric Acheson, MD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

General population scheduled for laparoscopic surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	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 at any time to standard of care (manual minimally invasive surgery) without the usage of the Maestro Platform, or to convert to open surgery.
Patients operated using the Maestro platform	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 at any time to standard of care (manual minimally invasive surgery) without the usage of the Maestro Platform, or to convert to open surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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	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 ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration		During procedure
Wheels-in Wheels-out	Timing and durations of Maestro's use in the procedure	During procedure
Skin to Skin time	Duration between the first incision and the last suture	During procedure
Recovery time	Assess whether the patient has fully recovered after 30 days	30 days
Turnaround time	Time between the start of two interventions compared to a baseline without the use of the Maestro System	During Procedure
Camera cleaning rate	the rate at which the surgeon extracts the endoscope from the patient to clean it	During procedure
Post operative pain	Visual analogue scale 0 - no pain to 10 - worst pain possible	1 day after the procedure
Potential post-operative complications		30 days
Human resource utilization for surgical assistance in the operating room	Number and type of staff in the OR during the procedure	During procedure
Surgeon comfort evaluated on 1-5 scale at the end of the procedure	1 - not comfortable 5 - very comfortable	During procedure
Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure	1 - not satisfied 5 - very satisfied	During procedure
Registry device preparation duration		During procedure
Incidence of procedure-specific complications		During procedure

Collaborators and Investigators

• Sponsor: Moon Surgical

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: abdominal laparoscopic surgery; surgical assistance device
• Other Study ID Numbers: Maestro1.1 PostMarket Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes