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| Name | Class |
|---|---|
| RQM+ | INDUSTRY |
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An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.
This is a prospective multi-center registry in which sites may also choose to retrospectively enroll subjects meeting the inclusion criteria, but whom have already been treated using the Senhance system. The data collection includes baseline patient characteristics, surgical details, and adverse events. Patient follow-up time point is open to the clinical practice of each center and only adverse events are tracked post discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senhance Treated | All patients enrolled who go on to have a surgery in which the Senhance system is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Device | Patients are approached surgically with the Senhance Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Any untoward sign symptom or disease | Surgery to 30 days post op |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patients at a participating center who have had or are scheduled to have surgery using the Senhance system
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Smith, PhD | Contact | 608-957-4850 | ssmith@asensus.com | |
| Monica Marini | Contact | +39 342 6268232 | mmarini@asensus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Marien-Krankenhaus | Recruiting | Siegen | 57072 | Germany |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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