Maestro 1.0 Post-Market Registry
Sponsor
Moon Surgical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06103136
Collaborator
(none)
400
2
6.1
200
32.9
Study Details
Study Description
Brief Summary
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Maestro 1.0 Post-Market Registry
Actual Study Start Date
:
Sep 29, 2023
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Apr 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Procedure-specific complications [During procedure]
- Procedure duration [During procedure]
- Wheels-in Wheels-out [During procedure]
Timing and durations of Maestro's use in the procedure
- Skin to Skin time [During procedure]
Duration between the first incision and the last suture
- Recovery time [30 days]
Assess whether the patient has fully recovered after 30 days
- Turnaround time [During Procedure]
Time between the start of two interventions compared to a baseline without the use of the Maestro System
- Camera cleaning rate [During procedure]
the rate at which the surgeon extracts the endoscope from the patient to clean it
- Post operative pain [1 day after the procedure]
Visual analogue scale 0 - no pain to 10 - worst pain possible
- Potential post-operative complications [30 days]
- Human resource utilization for surgical assistance in the operating room [During procedure]
Number and type of staff in the OR during the procedure
- Surgeon comfort evaluated on 1-5 scale at the end of the procedure [During procedure]
1 - not comfortable 5 - very comfortable
- Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure [During procedure]
1 - not satisfied 5 - very satisfied
- Registry device preparation duration [During procedure]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Polyclinique de Franche-Comté | Besançon | France | 25000 | |
| 2 | Institut Arnault Tzanck | Saint-Laurent-du-Var | France | 06700 |
Sponsors and Collaborators
- Moon Surgical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Moon Surgical
ClinicalTrials.gov Identifier:
NCT06103136
Other Study ID Numbers:
- Maestro1.0 PostMarket Registry
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moon Surgical