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NCT02248389 · ClinicalTrials.gov registry record · Phase 1
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
A Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02248389: Completed Phase 1 study, sponsored by Indiana University.
NCT02248389 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02248389, a Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
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.
Primary Outcome
Observing complications as defined by the Clavien system (1-5).
Interventions
- DEVICE Sonatherm 600i ablation system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-09-04 |
| Est. Completion | 2015-06-08 |
| Phase | Phase 1 |
What the finished NCT02248389 record still lists
NCT02248389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Sonatherm 600i ablation system is the first listed.
NCT02248389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02248389 about?
NCT02248389 is a clinical study titled "Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses". 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 r...
What is the current status of trial NCT02248389?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-09-04. Estimated completion is 2015-06-08.
What interventions are being tested in trial NCT02248389?
The interventions under investigation include: Sonatherm 600i ablation system (DEVICE).
Who is sponsoring clinical trial NCT02248389?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02248389's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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