Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Re… (NCT02248389) | Clinical Trial Compass
CompletedPhase 1
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
United States4 participantsStarted 2014-09-04
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age.
✓. Must provide written informed consent
✓. Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
✓. Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
✓. Must have an expected survival status of at least 3 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
✓. Previous chemotherapy, and/or biological therapy for cancer are permitted. The subject should have recovered from the effects of these or of any prior surgery.
✓. Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment. Females must agree to adequate birth control if conception is possible during the study.
Exclusion criteria
✕. \< 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)