Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery (NCT05243433) | Clinical Trial Compass
CompletedNot Applicable
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
Belgium50 participantsStarted 2022-04-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 locati…
What they're measuring
1
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
Timeframe: 30 days
2
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