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NCT01557387 · ClinicalTrials.gov registry record
Real-time Diagnosis of Pseudopolyps During Colonoscopy
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 75
- Enrollment target
NCT01557387 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 75 participants.
The verdict
NCT01557387 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study Summary
Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions. Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying techniques using indigo carmine which will predict diagnosis without biopsy. 100 patients with inflammatory bowel disease will be enrolled in the study. Following a standard bowel preparation, each patient will be evaluated using standard endoscopic equipment. All patients will receive a standard bowel preparation (sodium phosphate, PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be performed for indications unrelated to the present study, including evaluation of response to medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding. Polypoid lesions will be examined using four consecutive methods: (a) high definition white light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa surrounding the polypoid lesions will also be examined using theses four techniques in an effort to identify dysplastic tissue associated with these polypoid growths. High definition white light is the standard imaging modality used for colonoscopy. Narrow band imaging (blue wavelength of light) is also used routinely and is available on all current generation colonoscopes with the press of a button. Our division routinely uses chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa. The dye used will be indigo carmine. Directed biopsy specimens will then be
Interventions
- OTHER Endoscopic techniques
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01557387
The ClinicalTrials.gov registry entry for NCT01557387 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endoscopic techniques is the first listed.
NCT01557387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01557387 about?
NCT01557387 is a clinical study titled "Real-time Diagnosis of Pseudopolyps During Colonoscopy". Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions. Hypothesis: Pseudopolyps will have a distinctive...
What is the current status of trial NCT01557387?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2011-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01557387?
The interventions under investigation include: Endoscopic techniques (OTHER).
Who is sponsoring clinical trial NCT01557387?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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