Confocal Endomicroscopy for GI Neoplasia Study

This study has been completed.
Sponsor:
Collaborator:
Bankhead-Coley
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01515514
First received: January 10, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition
Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Endomicroscopy for GI Neoplasia Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Quality of the confocal image [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.


Enrollment: 40
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Approximately 40 patients with polyps

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515514

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Bankhead-Coley
Investigators
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Michael Wallace, Primary Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01515514     History of Changes
Other Study ID Numbers: 11-006327
Study First Received: January 10, 2012
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
polyps
inflammatory bowel disease
associated neoplasia

Additional relevant MeSH terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Polyps
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014