Status:
COMPLETED
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
Lead Sponsor:
Moon Surgical
Conditions:
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05243433
Start Date
April 11 2022
End Date
May 5 2023
Last Update
August 23 2023
Active Locations (1)
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1
CHU St Pierre
Brussels, Belgium