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Recruiting

NCT Number: NCT06103136

Maestro 1.1 Post-Market Registry

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

Recruiting

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Key information

Conditions

Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chirec Delta, Auderghem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants will be adults aged ≥ 18 years scheduled for laparoscopic surgery.

Exclusion criteria

  • Participants might be excluded based on the investigator's discretion.

Treatment and study plan

Laparoscopic surgery using the Maestro Platform

Device

Patients scheduled for laparoscopic surgery will be operated on as per standard of care, using standard port, surgical table and instrument placements (following local applicable guidelines), and off-the-shelf surgical equipment. Standard of care surgical technique following local applicable guidelines will be used.

The Maestro Platform may be used to position and hold the scope as well as the retractor in the locations determined by the surgeon during the procedure, with the ability to revert at any time to standard of care (manual minimally invasive surgery) without the usage of the Maestro Platform, or to convert to open surgery.

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: 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

Secondary outcomes

  1. Incidence of procedure-specific complications

    Time frame: During procedure

  2. Procedure duration

    Time frame: During procedure

  3. Wheels-in Wheels-out

    Time frame: During procedure

    Timing and durations of Maestro's use in the procedure

  4. Skin to Skin time

    Time frame: During procedure

    Duration between the first incision and the last suture

  5. Recovery time

    Time frame: 30 days

    Assess whether the patient has fully recovered after 30 days

  6. Turnaround time

    Time frame: During Procedure

    Time between the start of two interventions compared to a baseline without the use of the Maestro System

  7. Camera cleaning rate

    Time frame: During procedure

    the rate at which the surgeon extracts the endoscope from the patient to clean it

  8. Post operative pain

    Time frame: 1 day after the procedure

    Visual analogue scale 0 - no pain to 10 - worst pain possible

  9. Potential post-operative complications

    Time frame: 30 days

  10. Human resource utilization for surgical assistance in the operating room

    Time frame: During procedure

    Number and type of staff in the OR during the procedure

  11. Surgeon comfort evaluated on 1-5 scale at the end of the procedure

    Time frame: During procedure

    1 - not comfortable 5 - very comfortable

  12. Surgeon satisfaction with Maestro evaluated on 1-5 scale at the end of the procedure

    Time frame: During procedure

    1 - not satisfied 5 - very satisfied

  13. Registry device preparation duration

    Time frame: During procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Osdoit

CONTACT

[email protected]

6 60 42 28 31 ext. +33

Sponsors and collaborators

Lead sponsor

Moon Surgical

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2023
Registry last updated
Feb 12, 2025

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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