Recruiting

Observational Study

Sponsor:

Moon Surgical

Code:

NCT06103136

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Laparoscopic surgery using the Maestro Platform

Study Details

Brief summary:

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

Conditions

Surgery

Study ID

NCT06103136

Start date

Sep 29, 2023

Status verified date

Feb, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients operated using the Maestro platform

Control

Interventions

Laparoscopic surgery using the Maestro Platform

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 outcome 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 [ 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 ] ]
  • 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 ]

Central Contacts and Locations

Central contacts

Anne Osdoit

6 60 42 28 31aosdoit@moonsurgical.com

Locations

Rose Medical Center

Recruiting

Denver, Colorado, United States, 80220

Lee Health

Recruiting

Fort Myers, Florida, United States, 33907

Baptist Health

Recruiting

Jacksonville, Florida, United States, 32207

Baptist Medical Center Beaches

Recruiting

Jacksonville, Florida, United States, 32250

Orlando Veterans Affairs Medical Center

Recruiting

Orlando, Florida, United States, 32827-5812

Surgeon's Point ASC

Recruiting

Cedar Park, Texas, United States, 78613

More Information

Sponsor

Moon Surgical

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Keywords

  • abdominal laparoscopic surgery
  • surgical assistance device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Moon Surgical on 2025-02-12.