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Study of KCC Peptide Application in the Colon
NCT02156557 · View on ClinicalTrials.gov ↗
Study Summary
We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scopes to see abnormal areas that are hard to see with the naked eye. The stain or dye is "fluorescent", meaning it glows when special light is used in the colonoscopy scope. You are being asked to let us spray a peptide with a fluorescent tag onto your colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. The peptide we use has 7 amino acids attached to a fluorescent tag ("FIT C" or Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye drops). We are testing this "fluorescent peptide" to see if it will stick if there are any abnormal areas. If the peptide "sticks", it will "glow" when a special light in the scope is used. In this study, we will apply the fluorescent peptide to your colon by using a spray tube that fits in the colonoscope. This is a phase IB study. This means that although we have applied the peptide to 25 people in our first research study, we still need to learn more about "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 main goal of this study is to see if the peptide "glows" well and if we can take pictures of areas that do glow. This is a research study of the peptide and our ability to see it "glow or fluoresce". Being in this study and applying the peptide won't change how our biopsies are taken or how your colonoscopy is done.
Conditions Studied
Interventions
- BIOLOGICAL Colon KCC Heptapeptide
Study Locations (1)
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02156557
The ClinicalTrials.gov registry entry for NCT02156557 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Danielle Kim Turgeon, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention — of which Colon KCC Heptapeptide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02156557 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02156557 about?
NCT02156557 is a clinical study titled "Study of KCC Peptide Application in the Colon". We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scope...
What is the current status of trial NCT02156557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-06. Estimated completion is 2016-08.
What conditions does trial NCT02156557 study?
This clinical trial studies the following conditions: Colorectal Cancer, Inflammatory Bowel Disease (IBD), Colon Polyps. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02156557?
The interventions under investigation include: Colon KCC Heptapeptide (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02156557?
This trial is sponsored by Danielle Kim Turgeon, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02156557 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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