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NCT01722058 · ClinicalTrials.gov registry record · Phase 1
A Phase I In-Vivo Peptide Applied in the Right Colon
A Phase 1 study of Colon Lesions, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01722058: Completed Phase 1 study of Colon Lesions, sponsored by University of Michigan.
NCT01722058 is a Phase 1 study of Colon Lesions that has completed, run by University of Michigan. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722058, a Phase 1 study of Colon Lesions, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We are looking at using special fluorescent stains in addition to special endoscopes designed to see abnormal areas that are not obvious to the naked eye. Currently specialized microscopes and fluorescent stains are used in clinical laboratories but it takes several days of processing to get results. It may be very helpful to look for areas to sample for abnormal tissue during the endoscopy procedure. You are being asked to let us spray a "fluorescent peptides" into your right colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor). We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas if present, and "glow" when a special light is used. In this study, we will apply the special fluorescent peptide by a spray catheter to your right colon to asses for safety. The colonoscope used in this study is the usual colonoscope used and is not able to see the fluorescence. This is a phase 1 study. This means that this is the first time we have used this kind of "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The goal of this study is to see if there are any side effects from using the peptide. We have used a similar peptide that we've developed for the esophagus in over 40 patients without any side effects. This is the first test of this agent, so it won't be used to change how colonoscopy is done.
Primary Outcome
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Conditions Studied
Interventions
- DRUG Peptide application
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01722058 record still lists
NCT01722058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Colon Lesions appearing as the primary indexed condition, and to 1 intervention - of which Peptide application is the first listed.
NCT01722058 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01722058 about?
NCT01722058 is a clinical study titled "A Phase I In-Vivo Peptide Applied in the Right Colon". You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We are looking at...
What is the current status of trial NCT01722058?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-02. Estimated completion is 2013-08.
What conditions does trial NCT01722058 study?
This clinical trial studies the following conditions: Colon Lesions.
What interventions are being tested in trial NCT01722058?
The interventions under investigation include: Peptide application (DRUG).
Who is sponsoring clinical trial NCT01722058?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01722058 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01722058's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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