Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy.

Sonatherm 600i ablation system

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.

Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses

Observing complications as defined by the Clavien system (1-5).

A microscopic analysis will be performed to assess necrosis within the ablation zone.

The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.

A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses	NCT02248389	Carcinoma, Rena...	Sonatherm 600i ...	18 Years - 80 Years	Indiana University
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses	NCT02248389	Carcinoma, Rena...	Sonatherm 600i ...	18 Years - 80 Years	Indiana University

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