Clinical trial NCT05243433: Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
Official title: Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: abdominal laparoscopic surgery
laparoscopic cholecystectomy
laparoscopic hernia repair
laparoscopic appendectomy
laparoscopic bariatric surgery
laparoscopic colectomy
Lead sponsor: Moon Surgical
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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)

Primary outcomes:
measure: 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
measure: 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
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
measure: Procedure-specific complications
timeFrame: During procedure
measure: Procedure duration
timeFrame: During procedure
measure: Recovery time
timeFrame: 30 days
measure: Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible)
timeFrame: 1 day after procedure
measure: Number of rehospitalization per patient within 30 days
timeFrame: 30 days
measure: Number of repeat surgery or reintervention per patient within 30 days
timeFrame: 30 days
measure: Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable)
timeFrame: During procedure
measure: 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)
timeFrame: During procedure
measure: 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)
timeFrame: During procedure
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
Study officials:
affiliation: CHU Saint-Pierre, Brussels, Belgique
name: Guy-Bernard CADIERE, Pr
role: PRINCIPAL_INVESTIGATOR
References: