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Spots Global Cancer Trial Database for Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses

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Trial Identification

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

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

Study ID: NCT02248389

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

IU Health University Hospital, Indianapolis, Indiana, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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