Maestro 1.0 Post-Market Registry

Surgery Clinical Trial

Official title:

Maestro 1.0 Post-Market Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103136
• Other study ID #: Maestro1.0 PostMarket Registry
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Moon Surgical
• Contact: Anen Osdoit
• Phone: 6 60 42 28 31
• Email: aosdoit[@]moonsurgical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Polyclinique de Franche-Comté	Besançon
France	Institut Arnault Tzanck	Saint-Laurent-du-Var

Sponsors (1)

Lead Sponsor	Collaborator
Moon Surgical

Country where clinical trial is conducted

France, 

Outcome

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