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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 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 4 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02248389
The ClinicalTrials.gov registry entry for NCT02248389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sonatherm 600i ablation system is the first listed.
NCT02248389 reports 0 study locations.
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.
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