Confocal Endomicroscopy for GI Neoplasia Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01515514

Enrollment

Registered

2012-01-24

Start date

2012-08-31

Completion date

2012-11-30

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyps

Keywords

polyps, inflammatory bowel disease, associated neoplasia

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of the confocal image	1 yr	Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.

Countries

United States

Outcome results