Surgery
Conditions
Keywords
abdominal laparoscopic surgery, laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery, laparoscopic colectomy
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.
Interventions
Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.
Sponsors
Moon Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Recovery time | 30 days |
| Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible) | 1 day after procedure |
| Number of rehospitalization per patient within 30 days | 30 days |
| Procedure-specific complications | During procedure |
| Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable) | During procedure |
| Surgeon satisfaction with the level of assistance provided by the Maestro platform, on 1-10 scale at the end of the procedure (1-assistance much worse than a human assistant, 5-equivalent to human assistant, 10-much better than human assistant) | During procedure |
| Study device usability on 1-10 scale at the end of the procedure (1-very hard to use, 5-not difficult but not easy, 10-very easy to use) | During procedure |
| Number of repeat surgery or reintervention per patient within 30 days | 30 days |
| Procedure duration | During procedure |
Countries
Belgium
Outcome results
None listed