Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
Conditions
Keywords
laparoscopic Cholecystectomy, laparoscope holder, gynecological laparoscopy procedures, fundoplication surgery, laparoscopic adnexal surgery, excision of endometriosis lesion, diagnostic laparoscopy procedures, right hemicolectomy, Diaphragmatic hernia
Brief summary
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
Interventions
DEVICEAutoLap
Sponsors
M.S.T. Medical Surgery Technology LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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
Exclusion criteria
1. Pregnancy 2. Extensive adhesions that will preclude routine laparoscopic surgical approach. 3. American Society of Anesthesiologists' (ASA) classification\>2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| System set-up time | during surgery |
| Number of times that the laparoscope was removed for cleaning | during surgery |
| AutoLap evaluation questionnaire | post surgery |
| Number of successful Follow Me movements | during surgery |
| Length of procedure | during surgery |
Secondary
| Measure | Time frame |
|---|---|
| System repositioning | during surgery |
Other
| Measure | Time frame |
|---|---|
| Surgeon's learning curve for the use of the AutoLap system | post surgery |
Countries
Israel, Netherlands
Outcome results
None listed