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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10346 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22446 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port [SP]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.
OUTLINE:
Patients undergo surgery using the da Vinci SP1098 robotic system on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device feasibility (da Vinci SP1098 robotic system) | Experimental | Patients undergo surgery using the da Vinci SP1098 robotic system on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Assisted Surgery | Device | Undergo surgery using the da Vinci SP device |
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| Measure | Description | Time Frame |
|---|---|---|
| Conversion of operation to laparotomy | The number and frequency will be reported with 95% confidence intervals. | Within 30 days of operation |
| Incidence of major surgical complications | Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals. | Within 30 days of operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehdi Moslemi-Kebria | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |