Maestro 1.1 Post-Market Registry

February 11, 2025 updated by: Moon Surgical
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: During procedure
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
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 ]
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure duration
Time Frame: During procedure
During procedure
Wheels-in Wheels-out
Time Frame: During procedure
Timing and durations of Maestro's use in the procedure
During procedure
Skin to Skin time
Time Frame: During procedure
Duration between the first incision and the last suture
During procedure
Recovery time
Time Frame: 30 days
Assess whether the patient has fully recovered after 30 days
30 days
Turnaround time
Time Frame: During Procedure
Time between the start of two interventions compared to a baseline without the use of the Maestro System
During Procedure
Camera cleaning rate
Time Frame: During procedure
the rate at which the surgeon extracts the endoscope from the patient to clean it
During procedure
Post operative pain
Time Frame: 1 day after the procedure
Visual analogue scale 0 - no pain to 10 - worst pain possible
1 day after the procedure
Potential post-operative complications
Time Frame: 30 days
30 days
Human resource utilization for surgical assistance in the operating room
Time Frame: During procedure
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
Time Frame: During procedure
1 - not comfortable 5 - very comfortable
During procedure
Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure
Time Frame: During procedure
1 - not satisfied 5 - very satisfied
During procedure
Registry device preparation duration
Time Frame: During procedure
During procedure
Incidence of procedure-specific complications
Time Frame: During procedure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moon Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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