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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)
. Prior ablative or surgical treatment of the lesion
. Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
. The patient has only one kidney
. Multiple or bilateral renal masses
. Failure to meet the following laboratory levels on preoperative screening: