NCT05243433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

January 12, 2022

Last Update Submit

August 22, 2023

Conditions

Surgery

Keywords

abdominal laparoscopic surgerylaparoscopic cholecystectomylaparoscopic hernia repairlaparoscopic appendectomylaparoscopic bariatric surgerylaparoscopic colectomy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Procedure-specific complications

    During procedure

  • Procedure duration

    During procedure

  • Recovery time

    30 days

  • +6 more other outcomes

Study Arms (1)

Procedure using the Maestro Platform

EXPERIMENTAL

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

Interventions

Laparoscopic surgery using the Maestro PlatformDEVICE

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

Procedure using the Maestro Platform

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St Pierre

Brussels, Belgium

Location

Study Officials

  • Guy-Bernard CADIERE, Pr

    CHU Saint-Pierre, Brussels, Belgique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 17, 2022

Study Start

April 11, 2022

Primary Completion

April 5, 2023

Study Completion

May 5, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

BE(1)