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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 is a Early Phase 1 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357121
The ClinicalTrials.gov registry entry for NCT02357121 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Focal Laser Ablation is the first listed.
NCT02357121 reports 0 study locations.
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.
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