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

Surgery Clinical Trial

— Maestro  

Official title:

Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243433
• Other study ID #: Maestro LIFT-OFF
• Status: Completed
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: August 2023
• Source: Moon Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Laparoscopic surgery using the Maestro Platform
Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.

Locations

Country	Name	City	State
Belgium	CHU St Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Moon Surgical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure-specific complications		During procedure
Other	Procedure duration		During procedure
Other	Recovery time		30 days
Other	Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible)		1 day after procedure
Other	Number of rehospitalization per patient within 30 days		30 days
Other	Number of repeat surgery or reintervention per patient within 30 days		30 days
Other	Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable)		During procedure
Other	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
Other	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
Primary	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
Primary	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