NCT05218811

Brief 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 renal ischemia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
183mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
May 2020May 2041

Study Start

First participant enrolled

May 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2041

Expected
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

6 years

First QC Date

September 26, 2021

Last Update Submit

January 24, 2023

Conditions

Kidney Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Recurrence - Oncological Control

    Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis

    10 Years

Secondary Outcomes (4)

  • Local Re-Intervention

    10 Years

  • Development or Progression of Chronic Kidney Disease (CKD)

    10 Years

  • Incidence of Metastatic disease

    10 Years

  • Survival

    10 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients underwent Cryotheapy assisted partial nephrectomy

Device: Cryoablation Assisted Partial Nephrectomy

Interventions

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.

Treatment group

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ages between 45-90-year-old.
  • Renal tumor ≤ 7 cm in the greatest extension, \>50% exophitic.

You may not qualify if:

  • Prior renal surgery
  • M1 Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urological Research Network

Miami Lakes, Florida, 33016, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29890126BACKGROUND

  • Makki 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.

    PMID: 31842655BACKGROUND

  • Berger 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.

    PMID: 19188767BACKGROUND

  • Ushijima 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.

    PMID: 33205290BACKGROUND

  • Zargar 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.

    PMID: 25819723BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Fernando J Bianco, MD

    Urological research Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eusebio J Luna, MD

CONTACT

3058227227drluna@research.surgery

Cielo Guerra

CONTACT

3058227227cielo@besturology.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2021

First Posted

February 1, 2022

Study Start

May 15, 2020

Primary Completion

May 15, 2026

Study Completion (Estimated)

May 15, 2041

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

US(1)