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NCT02357121 · ClinicalTrials.gov registry record · Early Phase 1
Focal Laser Ablation of Prostate Tissue
A Early Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT02357121: Completed Early Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT02357121 is a Early Phase 1 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02357121, a Early Phase 1 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.
Primary Outcome
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
Interventions
- DEVICE Focal Laser Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-09-17 |
| Est. Completion | 2019-08-20 |
| Phase | Early Phase 1 |
What the finished NCT02357121 record still lists
NCT02357121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Focal Laser Ablation is the first listed.
NCT02357121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02357121 about?
NCT02357121 is a clinical study titled "Focal Laser Ablation of Prostate Tissue". This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermist...
What is the current status of trial NCT02357121?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2015-09-17. Estimated completion is 2019-08-20.
What interventions are being tested in trial NCT02357121?
The interventions under investigation include: Focal Laser Ablation (DEVICE).
Who is sponsoring clinical trial NCT02357121?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02357121's enrollment target sits among peer trials
11 1601st of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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