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Completed

NCT Number: NCT05243433

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU St Pierre

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laparoscopic surgery using the Maestro Platform

Device

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

Primary outcomes

  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

    Time frame: 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

    Time frame: During procedure

Other outcomes

  1. Procedure-specific complications

    Time frame: During procedure

  2. Procedure duration

    Time frame: During procedure

  3. Recovery time

    Time frame: 30 days

  4. Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible)

    Time frame: 1 day after procedure

  5. Number of rehospitalization per patient within 30 days

    Time frame: 30 days

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

    Time frame: 30 days

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

    Time frame: 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)

    Time frame: 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)

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Moon Surgical

Industry

Registry information

Official study title

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

Acronym: Maestro

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2022
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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