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Not meeting primary objective of the study
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This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10mm Cannula | Subjects that are scheduled for a robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannula and Blunt Obturator | Device | The FloShield 10mm Endoscopic Cannula and Blunt Obturator will be used to maintain access to the peritoneal cavity during robot-assisted single site laparoscopic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate | Completion rate is the percentage of users who successfully complete the task without critical errors. A critical error is defined as an error that results in an incorrect or incomplete outcome (Grade 1 and 2). In other words, the completion rate represents the percentage of participants who, when they are finished with the specified task, have an "output" that is correct (Grade 3 - 5). Note: If a participant requires assistance in order to achieve a correct output then the task will be scored as a critical error and the overall completion rate for the task will be affected. A completion rate of 90% is the goal for each task in this usability test. | 1 - 4hr (Initial insertion to final withdrawal of the laparoscope) |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | The secondary outcome from the study will be an assessment of the performance of the FloShield 10mm Cannula and Oburator/FloShield System in its ability to defog and clean the laparoscopic lens. | 1 - 4hr (Initial insertion to final withdrawal of the laparoscope) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from a population of patients who are from the medical practice of the study investigator and who are scheduled to undergo robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Poll, MD | Minimally Invasive Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Florida | Miami | Florida | 33183 | United States |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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