Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery (Maestro)

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Laparoscopic surgery using the Maestro Platform

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne ODSOIT; Phone Number: +33 6 60 42 28 31; Email: aosdoit@sofinnovapartners.com

Study Locations

• Belgium
  • Brussels, Belgium
    • Chu St Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Procedure using the Maestro Platform; 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.	Device: Laparoscopic surgery using the Maestro Platform; Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Procedure-specific complications	During procedure
Procedure duration	During procedure
Recovery time	30 days
Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible)	1 day after procedure
Number of rehospitalization per patient within 30 days	30 days
Number of repeat surgery or reintervention per patient within 30 days	30 days
Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable)	During procedure
Surgeon satisfaction with the level of assistance provided by the Maestro platform, on 1-10 scale at the end of the procedure (1-assistance much worse than a human assistant, 5-equivalent to human assistant, 10-much better than human assistant)	During procedure
Study device usability on 1-10 scale at the end of the procedure (1-very hard to use, 5-not difficult but not easy, 10-very easy to use)	During procedure

Collaborators and Investigators

• Sponsor: Moon Surgical
• Investigators: Principal Investigator: Guy-Bernard CADIERE, Pr, CHU Saint-Pierre, Brussels, Belgique

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; laparoscopic bariatric surgery; laparoscopic appendectomy; abdominal laparoscopic surgery; laparoscopic hernia repair; laparoscopic colectomy
• Other Study ID Numbers: Maestro LIFT-OFF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No