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A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Surgical System in laparoscopic upper gastrointestinal procedures | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levita Magnetic Surgical System | Device | The Magnetic Surgical System (MSS), which was cleared for market in the U.S. most recently per 510(k) K252435 and is commercially available in Chile, is composed of two hand-held instruments: a Magnetic Grasper and an external Magnetic Controller. The Magnetic Grasper is comprised of two main components: a detachable Grasper Tip and a Shaft. The detachable Grasper Tip provided with the Magnetic Grasper is 6.5cm in length. An optional 12.5cm length detachable Grasper Tip may be used as a replacement for the 6.5cm Grasper Tip and can be used with the Shaft interchangeably. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. In this study the 6.5 Grasper Tip will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Device and/or Procedure Related Adverse Events | Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity. | From enrollment to end of follow up at 30 days. |
| Average Number of Ports | Ability to adequately retract the stomach, omentum, and small bowel to achieve effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated. | During index procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Colonial | Huechuraba | Santiago Metropolitan | 8580645 | Chile | ||
| Hospital Luis Tisne |
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|
| Peñalolén |
| Santiago Metropolitan |
| 7930124 |
| Chile |