The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.
This study uses a treat and resect model where ablation is followed by a partial nephrectomy. This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU ablation could improve hemostasis and blood loss.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
HIFU ablation of tumor.
IU Health University Hospital
Indianapolis, Indiana, United States
Operative and postoperative complications
Observing complications as defined by the Clavien system (1-5).
Time frame: 4-months
Necrosis
A microscopic analysis will be performed to assess necrosis within the ablation zone.
Time frame: 1-week
Tumor targeting
The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.
Time frame: 1-week
Surgeon rated ease of use
A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.
Time frame: 1-week
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