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

NCT02248389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-03-25

No results posted yet for this study

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.

Conditions

  • Carcinoma, Renal Cell

Interventions

DEVICE

Sonatherm 600i ablation system

HIFU ablation of tumor.

Sponsors & Collaborators

  • SonaCare Medical

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-04
Primary Completion
2015-06-08
Completion
2015-06-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248389 on ClinicalTrials.gov