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

Not Applicable

Completed

• Conditions: Surgery

• Registration Number: NCT05243433
• Lead Sponsor: Moon Surgical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-17
• Study Start: 2022-04-11
• Primary Completion: 2023-04-05
• Study Completion: 2023-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHU St Pierre; 🇧🇪 Brussels, Belgium