Bariatric Laparoscopic Surgery Candidate, General Laparoscopic Surgery Candidate
Conditions
Keywords
laparoscopic Cholecystectomy, laparoscope holder, Nissen fundoplication, paraesophageal hernia, sleeve surgery
Brief summary
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
Interventions
DEVICEAutoLap
Sponsors
M.S.T. Medical Surgery Technology LTD.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed and dated Informed Consent Form (ICF). 2. Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures
Exclusion criteria
1. Extensive adhesions that will preclude routine laparoscopic surgical approach. 2. Pregnancy 3. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image stability | during surgery, an expected average of 1 hour | measured by the vibrations of inertial sensors |
| Usability | post surgery, an expected average of 3 minutes | The ease of use of the AutoLap system will be evaluated by a set of questionnaires |
Secondary
| Measure | Time frame |
|---|---|
| System set-up time | during surgery, an expected average of 5 minutes |
| Length of surgery | during surgery, an expected average of 1 hour |
| The Number of times that the laparoscope was removed for cleaning | during surgery, an expected average of 1 hour |
Countries
United States
Outcome results
None listed