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

Moon Surgical

Status: Completed

Conditions: Surgery

Treatments: Device: Laparoscopic surgery using the Maestro Platform

Study type: Interventional

Funder types: Industry

Identifiers

NCT05243433

Maestro LIFT-OFF

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Procedure using the Maestro Platform

Experimental group

Description:

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.

Treatment:

Device: Laparoscopic surgery using the Maestro Platform