Cancer of Kidney
Conditions
Keywords
Cancer of the Kidney, Renal Cancer, Renal Neoplasms, Neoplasms, Kidney
Brief summary
Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long. This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided. The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.
Interventions
DEVICEMicrowave pre-coagulation
The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must have a solitary, polar, clinical T1 renal mass 2. Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation. 3. Women of child-bearing potential must have negative serum or urine pregnancy test 4. Patient must be able to give written informed consent 5. Patient must be 18 years or older 6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery
Exclusion criteria
1. T stage greater than clinical T1 2. Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland 3. Prior surgery or radiation therapy to the region of interest 4. Patient has a single functioning kidney 5. Patient has an uncorrectable coagulopathy 6. Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate. | 30 days prior to surgery (Baseline) and 6 weeks post surgery | We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | During the operation | To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time. |
| Clamp Time | During the operation | To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time. |
| Change in Renal Function | Within 30 days prior to operation and 6 weeks post operation | To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance. |
| Blood Loss | During the operation | To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss. |
| Tumor Margin | During the operation and 6 weeks post-operation | The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation. |
| Complication Rates | During the operation | Complication rates will be estimated using the methods of Kaplan and Meier. |
| Change in Functional Renal Volume | Within 30 days prior to operation and 6 weeks post-operation | To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Certus 140™ During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.
Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Certus 140™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.
We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)
Time frame: 30 days prior to surgery (Baseline) and 6 weeks post surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certus 140™ | To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate. | Baseline | 66 estimated Glomerular Filtration Rate |
| Certus 140™ | To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate. | 6 weeks post-surgery | 86 estimated Glomerular Filtration Rate |
| Certus 140™ | To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate. | Change from Baseline at 6 weeks | 20 estimated Glomerular Filtration Rate |
Secondary
Blood Loss
To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss.
Time frame: During the operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certus 140™ | Blood Loss | 300 mL |
Secondary
Change in Functional Renal Volume
To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI.
Time frame: Within 30 days prior to operation and 6 weeks post-operation
Population: Subject renal volume not measured. Only normal/abnormal renal function was assessed.
Secondary
Change in Renal Function
To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance.
Time frame: Within 30 days prior to operation and 6 weeks post operation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certus 140™ | Change in Renal Function | Baseline | 1.13 mg/dL (creatinine) |
| Certus 140™ | Change in Renal Function | 6 weeks | 0.90 mg/dL (creatinine) |
Secondary
Clamp Time
To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time.
Time frame: During the operation
Population: This 1 subject was not clamped during the operation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certus 140™ | Clamp Time | 0 minutes |
Secondary
Complication Rates
Complication rates will be estimated using the methods of Kaplan and Meier.
Time frame: During the operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certus 140™ | Complication Rates | 0 participants with complications |
Secondary
Operative Time
To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time.
Time frame: During the operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certus 140™ | Operative Time | 129 minutes |
Secondary
Tumor Margin
The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation.
Time frame: During the operation and 6 weeks post-operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certus 140™ | Tumor Margin | 0 percentage with tumor positive margins |