SurgeryNCT06103136
Maestro 1.1 Post-Market Registry
An observational study of Surgery, run by Moon Surgical at 12 sites in 3 countries.
Trial summary
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery
- What is being tested?
- Laparoscopic surgery using the Maestro Platform
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 29 Sep 2023to Dec 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population scheduled for laparoscopic surgery.
Who may be able to join
- Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.
Who cannot join
- Participants might be excluded based on the investigator's discretion.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
Surgeon's Point ASC
Cedar Park, Texas, 78613
Eric Acheson, MD, FACS
- Recruiting
Rose Medical Center
Denver, Colorado, 80220
Michael Snyder, MD, FACS
- Recruiting
Lee Health
Fort Myers, Florida, 33907
Thomas Bass, MD, FACS
- Recruiting
Baptist Health
Jacksonville, Florida, 32207
Steven Hodgett
- Recruiting
Baptist Medical Center Beaches
Jacksonville, Florida, 32250
Thomas Austgen, MD, FACS
- Recruiting
Orlando Veterans Affairs Medical Center
Orlando, Florida, 32827-5812
Jessica Feranec, MD, FACOG
France5 sites, 5 recruiting
- Recruiting
Polyclinique de Franche-Comté
Besançon, 25000
Henry Mercoli, Dr.
- Recruiting
Clinique Bouchard
Marseille
Marius Nedelcu, Dr.
- Recruiting
Hôpital Privé Arnault Tzanck
Mougin, Alpes Maritimes, 06250
Eugenio Benvenuto, Dr.
- Recruiting
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06700
Benjamin Cadière, Dr.
- Recruiting
Clinique de l'Orangerie
Strasbourg
Yannis Mesli, Dr
Belgium1 site, 1 recruiting
- Recruiting
Chirec Delta
Auderghem, 1160
Anne Catherine Dandrifosse
About this study
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
- Conditions
- Surgery
- Being tested
- Laparoscopic surgery using the Maestro Platform
- Keywords
- abdominal laparoscopic surgery, surgical assistance device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated using the Maestro platform | Not described Receives: Device: Laparoscopic surgery using the Maestro Platform | |
| Control | Not described Receives: Device: Laparoscopic surgery using the Maestro Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During procedure
Secondary outcomes (13)
Incidence of procedure-specific complications
Measured: During procedure
Procedure duration
Measured: During procedure
Wheels-in Wheels-out
Timing and durations of Maestro's use in the procedure
Measured: During procedure
Skin to Skin time
Duration between the first incision and the last suture
Measured: During procedure
Recovery time
Assess whether the patient has fully recovered after 30 days
Measured: 30 days
Turnaround time
Time between the start of two interventions compared to a baseline without the use of the Maestro System
Measured: During Procedure
Camera cleaning rate
the rate at which the surgeon extracts the endoscope from the patient to clean it
Measured: During procedure
Post operative pain
Visual analogue scale 0 - no pain to 10 - worst pain possible
Measured: 1 day after the procedure
Potential post-operative complications
Measured: 30 days
Human resource utilization for surgical assistance in the operating room
Number and type of staff in the OR during the procedure
Measured: During procedure
Surgeon comfort evaluated on 1-5 scale at the end of the procedure
1 - not comfortable 5 - very comfortable
Measured: During procedure
Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure
1 - not satisfied 5 - very satisfied
Measured: During procedure
Registry device preparation duration
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start29 Sep 2023
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Moon Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103136
- Sponsor's protocol ID
- Maestro1.1 PostMarket Registry
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maestro 1.1 Post-Market Registry
- ClinicalTrials.gov ID
- NCT06103136
- Acronym / sponsor ID
- Maestro1.1 PostMarket Registry
- Conditions
- Surgery
- Keywords
- abdominal laparoscopic surgery, surgical assistance device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Moon SurgicalIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients operated using the Maestro platform | – | Device: Laparoscopic surgery using the Maestro Platform |
| Control | – | Device: Laparoscopic surgery using the Maestro Platform |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population scheduled for laparoscopic surgery.
Key inclusion criteria (1 listed)
- Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.
Key exclusion criteria (1 listed)
- Participants might be excluded based on the investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgery using the Maestro PlatformPatients 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. | Device | Control, Patients operated using the Maestro platform |
Primary outcome
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 ]
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
13 secondary outcomes
Incidence of procedure-specific complications
Time frame: During procedure
Procedure duration
Time frame: During procedure
Wheels-in Wheels-out
Time frame: During procedure
Skin to Skin time
Time frame: During procedure
Recovery time
Time frame: 30 days
Turnaround time
Time frame: During Procedure
Camera cleaning rate
Time frame: During procedure
Post operative pain
Time frame: 1 day after the procedure
Potential post-operative complications
Time frame: 30 days
Human resource utilization for surgical assistance in the operating room
Time frame: During procedure
Surgeon comfort evaluated on 1-5 scale at the end of the procedure
Time frame: During procedure
Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure
Time frame: During procedure
Registry device preparation duration
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Moon Surgical at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Osdoit (6 60 42 28 31 ext. +33, aosdoit@moonsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.