SurgeryMaestroNCT05243433
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
A study testing Laparoscopic surgery using the Maestro Platform in people with Surgery, run by Moon Surgical at 1 site in Belgium.
Trial summary
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery
- What is being tested?
- Laparoscopic surgery using the Maestro Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Apr 2022to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 to ≤ 75 years
- Scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy.
- Willing to comply with protocol-specified follow-up evaluation
- Signed informed consent
Who cannot join
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus;
- Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
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- Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- Females who are pregnant, planning to become pregnant within three months of the procedure, or lactating;
- Extreme morbid obesity (BMI greater than 45 kg/m2);
- Patients presenting with ascites;
- Patients presenting for emergency surgery;
- Previous surgery in the same anatomical location;
- Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
- Conditions
- Surgery
- Being tested
- Laparoscopic surgery using the Maestro Platform
- Keywords
- abdominal laparoscopic surgery, laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery, laparoscopic colectomy
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
Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.
| Study group | Role | What they receive |
|---|---|---|
| Procedure using the Maestro Platform | Experimental | Study participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy. 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start11 Apr 2022
- Primary completion5 Apr 2023
- Study completion5 May 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moon Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy-Bernard CADIERE, Pr, Principal investigator, CHU Saint-Pierre, Brussels, Belgique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243433
- Sponsor's protocol ID
- Maestro LIFT-OFF
- Acronym
- Maestro
- Status last verified
- Aug 2023
- First submitted
- 12 Jan 2022
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05243433
- Acronym / sponsor ID
- Maestro / Maestro LIFT-OFF
- Conditions
- Surgery
- Keywords
- abdominal laparoscopic surgery, laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery, laparoscopic colectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Moon SurgicalIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 17 Feb 2022 (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 provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure using the Maestro Platform | Experimental | Device: Laparoscopic surgery using the Maestro PlatformStudy participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥ 18 to ≤ 75 years
- Scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy.
- Willing to comply with protocol-specified follow-up evaluation
- Signed informed consent
Key exclusion criteria (15 listed)
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus;
- Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
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 PlatformLaparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform. | Device | Procedure 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: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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. This study is not recruiting at the moment.
Guy-Bernard CADIERE, Pr principal investigator
CHU Saint-Pierre, Brussels, Belgique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery using the Maestro Platform in people with Surgery, run by Moon Surgical at 1 site in Belgium.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 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 23 Aug 2023.