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The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoLap | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active laparoscope positioner (AutoLap) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention | participants will be followed for the duration of hospital stay, an expected average of 1-2 days |
| Performance evaluation | The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position | during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). |
| Measure | Description | Time Frame |
|---|---|---|
| system set-up time | defined as the time required from connecting the AutoLap's ARM to the bed rail | during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). |
| Average total procedure time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Medical Center | Tel Aviv | Israel | 69710 | Israel | ||
| Niguarda Cà Granda Hospital |
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defined as the time from first abdominal incision until the surgical procedure is completed |
| during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). |
| Number of times that the laparoscope was removed for cleaning | During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed). |
| Usability evaluation | the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. The questionnaire assesses the surgeon's satisfaction with the use of the AutoLap in regard to easiness of use, convenient of movement control and its ability to be used in the OR without interfering with the surgical flow | During surgery (at the end of the procedure) |
| Milan |
| 20162 |
| Italy |
| Meander Medisch Centrum | Amersfoort | 3800BM | Netherlands |