Kidney NeoplasmsRCAPNNCT05218811
Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach
A study testing Cryoablation Assisted Partial Nephrectomy in people with Kidney Neoplasms, run by Urological Research Network, LLC at 1 site in United States.
Trial summary
Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial… Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Cryoablation Assisted Partial Nephrectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 15 May 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ages between 45-90-year-old.
- Renal tumor ≤ 7 cm in the greatest extension, >50% exophitic.
Who cannot join
- Prior renal surgery
- M1 Disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Urological Research Network
Miami Lakes, Florida, 33016
CIELO GUERRA, BS, 305-515-9887, CIELO@BESTUROLOGY.NET
FERNANDO J BIANCO, MD
About this study
Official title: Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.
Read the detailed description
Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are >2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia.
The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.
- Conditions
- Kidney Neoplasms
- Being tested
- Cryoablation Assisted Partial Nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation Assisted Partial NephrectomyDevice
Cryoablation Assisted Partial Nephrectomy is monitored under Ultrasound guidance, A Cryoablation machine (FDA Approved Device) along with its Cryoprobes are used in the study The Cryoprobes are placed in close to the endophytic tumor margins. The tumor boundary area will undergo one freezing cycles. Tumor is excised after 5 minutes of freezing cycle. Thawing process is passive, renal defect repair is conducted during thawing process.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients underwent Cryotheapy assisted partial nephrectomy Receives: Device: Cryoablation Assisted Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence - Oncological Control
Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis
Measured: 10 Years
Secondary outcomes (4)
Local Re-Intervention
Either subsequent ablation or surgical exploration or surgical kidney removal
Measured: 10 Years
Development or Progression of Chronic Kidney Disease (CKD)
De-Novo emergence of CDK or changes in CKD overtime based on variation from baseline. The international classification for CKD defined by serum estimated Glomerular Filtration Rates (GFR) will be used as measurement instrument using the following definitions:
GFR categories in CKD G1 ≥90 Normal or high G2 60-89 Mildly decreased* G3a 45-59 Mildly to moderately decreased G3b 30-44 Moderately to severely decreased
Measured: 10 Years
Incidence of Metastatic disease
patients will be evaluated using imaging studies at fixed intervals as follows: at 6 months Renal Ultrasound at 1 year CT Urogram at 18 Months, 24 months and yearly thereafter with Renal Ultrasound CT Urograms will be performed as needed for cause
Measured: 10 Years
Survival
If a patient expiries during the study interval we would procure the death certificate and do our best to determine cause of death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 May 2020
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies 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
- Model description
- Patients are scheduled for a surgical procedure: robotic partial nephrectomy, and the investigators will use a cryoablation probe(s) for selective ischemia rather than full blood flow interruption with a vascular clamp
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urological Research Network, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando J Bianco, MD, Principal investigator, Urological research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218811
- Sponsor's protocol ID
- URN-202000244
- Acronym
- RCAPN
- Status last verified
- Jan 2023
- First submitted
- 26 Sep 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ismail M, Nielsen TK, Lagerveld B, Garnon J, Breen D, King A, van Strijen M, Keeley FX Jr. Renal cryoablation: Multidisciplinary, collaborative and perspective approach. Cryobiology. 2018 Aug;83:90-94. doi: 10.1016/j.cryobiol.2018.06.002. Epub 2018 Jun 8.
PubMed 29890126Makki A, Aastrup MB, Vinter H, Ginnerup B, Graumann O, Borre M, Nielsen TK. Renal cryoablation - does deep endophytic ablation affect the renal collecting system? Scand J Urol. 2020 Feb;54(1):33-39. doi: 10.1080/21681805.2019.1702094. Epub 2019 Dec 16.
PubMed 31842655Berger A, Kamoi K, Gill IS, Aron M. Cryoablation for renal tumors: current status. Curr Opin Urol. 2009 Mar;19(2):138-42. doi: 10.1097/MOU.0b013e328323f618.
PubMed 19188767Ushijima Y, Asayama Y, Nishie A, Takayama Y, Kubo Y, Ishimatsu K, Ishigami K. Cryoablation for Secondary Renal Cell Carcinoma After Surgical Nephrectomy. Cardiovasc Intervent Radiol. 2021 Mar;44(3):414-420. doi: 10.1007/s00270-020-02709-w. Epub 2020 Nov 17.
PubMed 33205290Zargar H, Atwell TD, Cadeddu JA, de la Rosette JJ, Janetschek G, Kaouk JH, Matin SF, Polascik TJ, Zargar-Shoshtari K, Thompson RH. Cryoablation for Small Renal Masses: Selection Criteria, Complications, and Functional and Oncologic Results. Eur Urol. 2016 Jan;69(1):116-28. doi: 10.1016/j.eururo.2015.03.027. Epub 2015 Mar 26.
PubMed 25819723
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
- ClinicalTrials.gov ID
- NCT05218811
- Acronym / sponsor ID
- RCAPN / URN-202000244
- Conditions
- Kidney Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Urological Research Network, LLCUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2041 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.
Detailed description
Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are >2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia.
The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are scheduled for a surgical procedure: robotic partial nephrectomy, and the investigators will use a cryoablation probe(s) for selective ischemia rather than full blood flow interruption with a vascular clamp
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Cryoablation Assisted Partial NephrectomyPatients underwent Cryotheapy assisted partial nephrectomy |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ages between 45-90-year-old.
- Renal tumor ≤ 7 cm in the greatest extension, >50% exophitic.
Key exclusion criteria (2 listed)
- Prior renal surgery
- M1 Disease
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 |
|---|---|---|
| Cryoablation Assisted Partial NephrectomyCryoablation Assisted Partial Nephrectomy is monitored under Ultrasound guidance, A Cryoablation machine (FDA Approved Device) along with its Cryoprobes are used in the study The Cryoprobes are placed in close to the endophytic tumor margins. The tumor boundary area will undergo one freezing cycles. Tumor is excised after 5 minutes of freezing cycle. Thawing process is passive, renal defect repair is conducted during thawing process. | Device | Treatment group |
Primary outcome
Recurrence - Oncological Control
Time frame: 10 Years
Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis
4 secondary outcomes
Local Re-Intervention
Time frame: 10 Years
Development or Progression of Chronic Kidney Disease (CKD)
Time frame: 10 Years
Incidence of Metastatic disease
Time frame: 10 Years
Survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 29890126Ismail M, Nielsen TK, Lagerveld B, Garnon J, Breen D, King A, van Strijen M, Keeley FX Jr. Renal cryoablation: Multidisciplinary, collaborative and perspective approach. Cryobiology. 2018 Aug;83:90-94. doi: 10.1016/j.cryobiol.2018.06.002. Epub 2018 Jun 8.
- Background: PubMed 31842655Makki A, Aastrup MB, Vinter H, Ginnerup B, Graumann O, Borre M, Nielsen TK. Renal cryoablation - does deep endophytic ablation affect the renal collecting system? Scand J Urol. 2020 Feb;54(1):33-39. doi: 10.1080/21681805.2019.1702094. Epub 2019 Dec 16.
- Background: PubMed 19188767Berger A, Kamoi K, Gill IS, Aron M. Cryoablation for renal tumors: current status. Curr Opin Urol. 2009 Mar;19(2):138-42. doi: 10.1097/MOU.0b013e328323f618.
- Background: PubMed 33205290Ushijima Y, Asayama Y, Nishie A, Takayama Y, Kubo Y, Ishimatsu K, Ishigami K. Cryoablation for Secondary Renal Cell Carcinoma After Surgical Nephrectomy. Cardiovasc Intervent Radiol. 2021 Mar;44(3):414-420. doi: 10.1007/s00270-020-02709-w. Epub 2020 Nov 17.
- Background: PubMed 25819723Zargar H, Atwell TD, Cadeddu JA, de la Rosette JJ, Janetschek G, Kaouk JH, Matin SF, Polascik TJ, Zargar-Shoshtari K, Thompson RH. Cryoablation for Small Renal Masses: Selection Criteria, Complications, and Functional and Oncologic Results. Eur Urol. 2016 Jan;69(1):116-28. doi: 10.1016/j.eururo.2015.03.027. Epub 2015 Mar 26.
Related trials for Kidney Neoplasms
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingPhase 2
Neoadjuvant Belzutifan Plus Pembrolizumab in High-Risk, Locally Advanced Clear Cell Renal Cell Carcinoma
Locally Advanced Clear Cell Renal Cell Carcinoma
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.
Fernando J Bianco, MD principal investigator
Urological research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation Assisted Partial Nephrectomy in people with Kidney Neoplasms, run by Urological Research Network, LLC 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Jan 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eusebio J Luna, MD (3058227227, drluna@research.surgery), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence - Oncological Control (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218811, which also lists 5 linked publications.
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 Jan 2023.