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NCT02240498 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
A Phase 1 study of Abscess, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02240498 is a Phase 1 study of Abscess that has completed, run by University of Rochester. The registered enrollment target is 21 participants, below the 388-participant average among 13 other Abscess trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02240498, a Phase 1 study of Abscess, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this Phase 1 study are to evaluate the safety and feasibility of methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and imaging and laboratory studies in order to identify adverse events that may be induced by MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient population. Optical measurements will additionally be performed at the abscess wall to determine optical properties and methylene blue uptake.
Conditions Studied
Interventions
- DRUG Methylene Blue
- DRUG 20% I.V. Fat Emulsion
- DEVICE Insertion of optical fiber
- DEVICE Laser illumination, 5 minutes
- DEVICE Laser illumination, 10 minutes
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-09 |
| Est. Completion | 2023-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02240498
The ClinicalTrials.gov registry entry for NCT02240498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 388-participant average among 13 other Abscess trials with a reported enrollment target (95% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Abscess appearing as the primary indexed condition, and to 5 interventions - of which Methylene Blue is the first listed.
NCT02240498 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02240498 about?
NCT02240498 is a clinical study titled "Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities". The objectives of this Phase 1 study are to evaluate the safety and feasibility of methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and imaging and laboratory studies in or...
What is the current status of trial NCT02240498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2014-09. Estimated completion is 2023-09.
What conditions does trial NCT02240498 study?
This clinical trial studies the following conditions: Abscess.
What interventions are being tested in trial NCT02240498?
The interventions under investigation include: Methylene Blue (DRUG), 20% I.V. Fat Emulsion (DRUG), Insertion of optical fiber (DEVICE), Laser illumination, 5 minutes (DEVICE), Laser illumination, 10 minutes (DEVICE).
Who is sponsoring clinical trial NCT02240498?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02240498 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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