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CompletedNCT01515514Updated May 17, 2013

Confocal Endomicroscopy for GI Neoplasia Study

An observational study in Colorectal Polyps, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-17.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.

Read the detailed description

The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.

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Conditions studied

  • Colorectal Polyps

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Keywords

  • polyps
  • inflammatory bowel disease
  • associated neoplasia
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 40 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Approximately 40 patients with polyps

Inclusion criteria

  • Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.

Exclusion criteria

Exclusion Criteria:

  • Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
06

What researchers measure

Primary outcomes

  1. Quality of the confocal image

    Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.

    Time frame: 1 yr

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Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01515514
Lead sponsor
Mayo Clinic
Collaborators
Bankhead-Coley
Responsible party
Michael Wallace (Primary Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 24, 2012
Start date
Aug 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
May 17, 2013

Study contacts

Michael B Wallace, MD,MPH
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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