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

Study Overview
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Brief Summary
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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.

Official Title
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Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery

Conditions
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Surgery

Intervention / Treatment
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* Device: Laparoscopic surgery using the Maestro Platform


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedure using the Maestro Platform<br>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<br>* Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal laparoscopic surgery, laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery, laparoscopic colectomy