Kidney Neoplasm Clinical Trial
Official title:
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Verified date | June 2011 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation
Status | Completed |
Enrollment | 13 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology. 2. Bilateral renal function on radiographic imaging. 3. Willing to consent to randomization. 4. Willing to comply with study protocol. Exclusion Criteria: 1. Anatomically or functionally solitary kidney 2. Multiple renal tumours 3. Bilateral renal tumours 4. Life expectancy < 3 months as deemed by treating physician 5. Age less than 18 years old 6. Pregnancy |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measures of renal function uCrCl be performed for estimation of renal function | 3 months | No | |
Secondary | Post-operative complication | 3 months | Yes |
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