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Study was terminated. P.I. left the institution before completing study
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| Name | Class |
|---|---|
| Louis A. Weiss Memorial Hospital | OTHER |
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The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer assisted surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer assisted surgery | Device | use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patency of Graft Anastomosis | 30 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Femoral Artery Dissection and Anastomosis | 1 day | |
| Improvement in ABI Measurement of 0.15 or Better | 3 month, 6 month, 1 year | |
| Death |
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Inclusion Criteria:
Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Weiss Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Computer Assisted Surgery | Computer assisted surgery: use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is to verify that all efforts have been done to contact the PI, however the PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.
Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.
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| ID | Title | Description |
|---|---|---|
| BG000 | Computer Assisted Surgery | Computer assisted surgery: use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Trial terminated by Principal Investigator and the Principal Investigator has left the institution. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patency of Graft Anastomosis | The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data. | Posted | 30 Day |
|
|
The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.
The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.
Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.
All efforts have been done to contact the PI and to gather data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Computer Assisted Surgery | Computer assisted surgery: use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shirley Rodriguez | University of Chicago | 773-834-4337 | srodrigu@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
death |
| 30day, 1 year |
| Chicago |
| Illinois |
| 60640 |
| United States |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Trial terminated by Principal Investigator and the Principal Investigator has left the institution. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
| Secondary | Time for Femoral Artery Dissection and Anastomosis | The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data. | Posted | 1 day |
|
|
| Secondary | Improvement in ABI Measurement of 0.15 or Better | The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data. | Posted | 3 month, 6 month, 1 year |
|
|
| Secondary | Death | death | The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data. | Posted | 30day, 1 year |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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