Cancer of KidneyNCT01931462
Microwave Coagulation in Partial Nephrectomy Protocol
A study testing Microwave pre-coagulation in people with Cancer of Kidney, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Kidney
- What is being tested?
- Microwave pre-coagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a solitary, polar, clinical T1 renal mass
- 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.
- Women of child-bearing potential must have negative serum or urine pregnancy test
- Patient must be able to give written informed consent
- Patient must be 18 years or older
- No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery
Who cannot join
- T stage greater than clinical T1
- Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
- Prior surgery or radiation therapy to the region of interest
- Patient has a single functioning kidney
- Patient has an uncorrectable coagulopathy
- Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors
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.
- Conditions
- Cancer of Kidney
- Being tested
- Microwave pre-coagulation
- Keywords
- Cancer of the Kidney, Renal Cancer, Renal Neoplasms, Neoplasms, Kidney
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave pre-coagulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Certus 140™ | Experimental | During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor. Receives: Device: Microwave pre-coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days prior to surgery (Baseline) and 6 weeks post surgery
Secondary outcomes (7)
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.
Measured: During the operation
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.
Measured: During the operation
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.
Measured: During the operation
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.
Measured: Within 30 days prior to operation and 6 weeks post operation
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.
Measured: Within 30 days prior to operation and 6 weeks post-operation
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.
Measured: During the operation and 6 weeks post-operation
Complication Rates
Complication rates will be estimated using the methods of Kaplan and Meier.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer of KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E Jason Abel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931462
- Sponsor's protocol ID
- 2013-1080
- Status last verified
- Jan 2018
- First submitted
- 23 Aug 2013
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors
- ClinicalTrials.gov ID
- NCT01931462
- Acronym / sponsor ID
- 2013-1080
- Conditions
- Cancer of Kidney
- Keywords
- Cancer of the Kidney, Renal Cancer, Renal Neoplasms, Neoplasms, Kidney
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certus 140™ | Experimental | Device: Microwave pre-coagulationDuring the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have a solitary, polar, clinical T1 renal mass
- 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.
- Women of child-bearing potential must have negative serum or urine pregnancy test
- Patient must be able to give written informed consent
- Patient must be 18 years or older
Key exclusion criteria (6 listed)
- T stage greater than clinical T1
- Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
- Prior surgery or radiation therapy to the region of interest
- Patient has a single functioning kidney
- Patient has an uncorrectable coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave pre-coagulationThe 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. | Device | Certus 140™ |
Primary outcome
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.
Time frame: 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)
7 secondary outcomes
Blood Loss
Time frame: During the operation
Operative Time
Time frame: During the operation
Clamp Time
Time frame: During the operation
Change in Renal Function
Time frame: Within 30 days prior to operation and 6 weeks post operation
Change in Functional Renal Volume
Time frame: Within 30 days prior to operation and 6 weeks post-operation
Tumor Margin
Time frame: During the operation and 6 weeks post-operation
Complication Rates
Time frame: During the operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cancer of Kidney
Active, not recruitingPhase 1/2
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
Renal Cell Carcinoma
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
RecruitingPhase 2
Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer
Hereditary Leiomyomatosis and Renal Cell Carcinoma, Papillary Renal Cell Carcinoma
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Recruiting
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E Jason Abel, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave pre-coagulation in people with Cancer of Kidney, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days prior to surgery (Baseline) and 6 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.