Health TrialsbyHealthPanel

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

ConditionKidney Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-65
SponsorUrological Research Network, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ages between 45-90-year-old.

Renal tumor ≤ 7 cm in the greatest extension, >50% exophitic.

Disqualifiers

Prior renal surgery

M1 Disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryoablation Assisted Partial Nephrectomy

    Device

    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 groups

150 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence - Oncological Control

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

Time frame
10 Years

Secondary outcomes

1

Local Re-Intervention

Either subsequent ablation or surgical exploration or surgical kidney removal

Time frame
10 Years
2

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

Time frame
10 Years
3

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

Time frame
10 Years
4

Survival

If a patient expiries during the study interval we would procure the death certificate and do our best to determine cause of death

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Urological Research Network, LLC

Lead sponsor

Source ClinicalTrials.gov
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