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

Sponsor
Moon Surgical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05243433
Collaborator
(none)
30
1
1
7.7
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laparoscopic surgery using the Maestro Platform
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Procedure using the Maestro Platform

Study participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy.

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.

Outcome Measures

Primary Outcome Measures

  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 [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 [During procedure]

Other Outcome Measures

  1. Procedure-specific complications [During procedure]

  2. Procedure duration [During procedure]

  3. Recovery time [30 days]

  4. Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible) [1 day after procedure]

  5. Number of rehospitalization per patient within 30 days [30 days]

  6. Number of repeat surgery or reintervention per patient within 30 days [30 days]

  7. Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable) [During procedure]

  8. 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]

  9. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU St Pierre Brussels Belgium

Sponsors and Collaborators

  • Moon Surgical

Investigators

  • Principal Investigator: Guy-Bernard CADIERE, Pr, CHU Saint-Pierre, Brussels, Belgique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moon Surgical
ClinicalTrials.gov Identifier:
NCT05243433
Other Study ID Numbers:
  • Maestro LIFT-OFF
First Posted:
Feb 17, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Moon Surgical

Study Results

No Results Posted as of Aug 24, 2022