Trial Outcomes & Findings for Microwave Coagulation in Partial Nephrectomy Protocol (NCT NCT01931462)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

30 days prior to surgery (Baseline) and 6 weeks post surgery

Results posted on

2018-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Microwave Coagulation in Partial Nephrectomy Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certus 140™ n=2 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
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
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Blood Loss	300 mL

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Operative Time	129 minutes

SECONDARY outcome

Timeframe: During the operation

Population: This 1 subject was not clamped 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.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Clamp Time	0 minutes

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Change in Renal Function Baseline	1.13 mg/dL (creatinine)
Change in Renal Function 6 weeks	0.90 mg/dL (creatinine)

SECONDARY outcome

Timeframe: Within 30 days prior to operation and 6 weeks post-operation

Population: Subject renal volume not measured. Only normal/abnormal renal function was assessed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Tumor Margin	0 percentage with tumor positive margins

SECONDARY outcome

Timeframe: During the operation

Complication rates will be estimated using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Certus 140™ n=1 Participants 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.
Complication Rates	0 participants with complications

Adverse Events

Certus 140™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research, Department of Surgery

University of Wisconsin

Phone: 608-262-0540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60