NCT06103136

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
3 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

October 17, 2023

Last Update Submit

February 11, 2025

Conditions

Surgery

Keywords

abdominal laparoscopic surgerysurgical assistance device

Outcome Measures

Primary Outcomes (2)

  • 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 ]

  • 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

Secondary Outcomes (13)

  • Incidence of procedure-specific complications

    During procedure

  • Procedure duration

    During procedure

  • Wheels-in Wheels-out

    During procedure

  • Skin to Skin time

    During procedure

  • Recovery time

    30 days

  • +8 more secondary outcomes

Study Arms (2)

Patients operated using the Maestro platform

Device: Laparoscopic surgery using the Maestro Platform

Control

Device: Laparoscopic surgery using the Maestro Platform

Interventions

Laparoscopic surgery using the Maestro PlatformDEVICE

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.

ControlPatients operated using the Maestro platform

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population scheduled for laparoscopic surgery.

You may qualify if:

  • Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.

You may not qualify if:

  • Participants might be excluded based on the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Rose Medical Center

Denver, Colorado, 80220, United States

RECRUITING

Lee Health

Fort Myers, Florida, 33907, United States

RECRUITING

Baptist Health

Jacksonville, Florida, 32207, United States

RECRUITING

Baptist Medical Center Beaches

Jacksonville, Florida, 32250, United States

RECRUITING

Orlando Veterans Affairs Medical Center

Orlando, Florida, 32827-5812, United States

RECRUITING

Surgeon's Point ASC

Cedar Park, Texas, 78613, United States

RECRUITING

Chirec Delta

Auderghem, 1160, Belgium

RECRUITING

Hôpital Privé Arnault Tzanck

Mougin, Alpes Maritimes, 06250, France

RECRUITING

Polyclinique de Franche-Comté

Besançon, 25000, France

RECRUITING

Clinique Bouchard

Marseille, France

RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, 06700, France

RECRUITING

Clinique de l'Orangerie

Strasbourg, France

RECRUITING

Central Study Contacts

Anne Osdoit

CONTACT

6 60 42 28 31aosdoit@moonsurgical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 26, 2023

Study Start

September 29, 2023

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

FR(5)US(6)BE(1)