Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06103136

Maestro 1.1 Post-Market Registry for Surgical Assistance in Laparoscopic Surgery

Led by Moon Surgical · Updated on 2025-02-12

600

Participants Needed

12

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to observe how the Maestro Platform is used in real-world laparoscopic surgeries. The study focuses on monitoring the safety and performance of this surgical assistance device, evaluating its impact during procedures. The research is sponsored by Moon Surgical and includes adult patients undergoing laparoscopic surgery. Participants will have laparoscopic surgeries performed using the Maestro Platform, which assists by positioning and holding the surgical scope and retractor as guided by the surgeon. Standard surgical techniques and equipment are used alongside the device. Surgeons can switch back to manual minimally invasive surgery or convert to open surgery if needed during the procedure. During the study, researchers will track adverse events related to the device or procedure, procedure completion without device failure, and various procedure details such as duration, recovery time, and surgeon satisfaction. Measurements include monitoring complications, pain after surgery, device preparation time, and human resource use. Participants are followed for 30 days to assess safety and recovery outcomes.

CONDITIONS

Brief Title

Maestro 1.1 Post-Market Registry

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older scheduled for laparoscopic surgery
Not Eligible

You will not qualify if you...

  • Participants may be excluded based on the investigator's discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - During procedure

Participants undergo laparoscopic surgery using the Maestro Platform as part of their standard surgical procedure. The device assists in positioning and holding surgical instruments during the operation, with the option to revert to standard manual surgery if needed.

1 visit (in-person) on the day of surgery

Post-operative Follow-up

Duration - 30 days

Participants are monitored for adverse events, recovery progress, and potential complications following surgery.

Approximately 1 to 2 visits within 30 days post-surgery

Trial Site Locations

Total: 12 locations

1

Rose Medical Center

Denver, Colorado, United States, 80220

Actively Recruiting

2

Lee Health

Fort Myers, Florida, United States, 33907

Actively Recruiting

3

Baptist Health

Jacksonville, Florida, United States, 32207

Actively Recruiting

4

Baptist Medical Center Beaches

Jacksonville, Florida, United States, 32250

Actively Recruiting

5

Orlando Veterans Affairs Medical Center

Orlando, Florida, United States, 32827-5812

Actively Recruiting

6

Surgeon's Point ASC

Cedar Park, Texas, United States, 78613

Actively Recruiting

7

Chirec Delta

Auderghem, Belgium, 1160

Actively Recruiting

8

Hôpital Privé Arnault Tzanck

Mougin, Alpes Maritimes, France, 06250

Actively Recruiting

9

Polyclinique de Franche-Comté

Besançon, France, 25000

Actively Recruiting

10

Clinique Bouchard

Marseille, France

Actively Recruiting

11

Institut Arnault Tzanck

Saint-Laurent-du-Var, France, 06700

Actively Recruiting

12

Clinique de l'Orangerie

Strasbourg, France

Actively Recruiting

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Research Team

A

Anne Osdoit

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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