Safety and Performance Evaluation of the AutoLap System

M.S.T. Medical Surgery Technology

Status: Completed

Conditions: Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection

Treatments: Device: active laparoscope positioner (AutoLap)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01828580

AL-65-001

Details and patient eligibility

About

The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated Informed Consent Form.
2. Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.

Exclusion criteria

1. Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
2. Pregnancy.
3. Obesity (BMI >35 Kg/m2).
4. Generalized peritonitis.
5. Septic shock from cholangitis.
6. Severe acute pancreatitis.
7. Uncorrected coagulopathy.
8. Previous abdominal operations which prevent safe abdominal access or progression of the procedure.
9. Advanced cirrhosis with failure of hepatic function.
10. Suspected gallbladder cancer.
11. Acute cholecystitis
12. Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
13. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

AutoLap

Experimental group

Treatment:

Device: active laparoscope positioner (AutoLap)