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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2023-05-05

Brief Summary

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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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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laparoscopic surgery using the Maestro Platform

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No