Maestro 1.1 Post-Market Registry

NCT ID: NCT06103136

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients operated using the Maestro platform

Laparoscopic surgery using the Maestro Platform

Intervention Type DEVICE

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.

Control

Laparoscopic surgery using the Maestro Platform

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moon Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rose Medical Center

Denver, Colorado, United States

Site Status RECRUITING

Lee Health

Fort Myers, Florida, United States

Site Status RECRUITING

Baptist Health

Jacksonville, Florida, United States

Site Status RECRUITING

Baptist Medical Center Beaches

Jacksonville, Florida, United States

Site Status RECRUITING

Orlando Veterans Affairs Medical Center

Orlando, Florida, United States

Site Status RECRUITING

Surgeon's Point ASC

Cedar Park, Texas, United States

Site Status RECRUITING

Chirec Delta

Auderghem, , Belgium

Site Status RECRUITING

Hôpital Privé Arnault Tzanck

Mougin, Alpes Maritimes, France

Site Status RECRUITING

Polyclinique de Franche-Comté

Besançon, , France

Site Status RECRUITING

Clinique Bouchard

Marseille, , France

Site Status RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, , France

Site Status RECRUITING

Clinique de l'Orangerie

Strasbourg, , France

Site Status RECRUITING

Countries

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United States Belgium France

Central Contacts

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Anne Osdoit

Role: CONTACT

6 60 42 28 31 ext. +33

Facility Contacts

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Michael Snyder, MD, FACS

Role: primary

Thomas Bass, MD, FACS

Role: primary

Steven Hodgett

Role: primary

Thomas Austgen, MD, FACS

Role: primary

Jessica Feranec, MD, FACOG

Role: primary

Eric Acheson, MD, FACS

Role: primary

Anne Catherine Dandrifosse

Role: primary

Eugenio Benvenuto, Dr.

Role: primary

Henry Mercoli, Dr.

Role: primary

Marius Nedelcu, Dr.

Role: primary

Benjamin Cadière, Dr.

Role: primary

Yannis Mesli, Dr

Role: primary

Other Identifiers

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Maestro1.1 PostMarket Registry

Identifier Type: -

Identifier Source: org_study_id

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