NCT02248389

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DEVICE	Sonatherm 600i ablation system	HIFU ablation of tumor.

Timeline

• Start date: 2014-09-04
• Primary completion: 2015-06-08
• Completion: 2015-06-08
• First posted: 2014-09-25
• Last updated: 2019-03-25

Locations

1 site across 1 country: United States