NCT01515514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

January 10, 2012

Last Update Submit

May 15, 2013

Conditions

Colorectal Polyps

Keywords

polypsinflammatory bowel diseaseassociated neoplasia

Outcome Measures

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.

    1 yr

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 40 patients with polyps

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

PolypsInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Michael B Wallace, MD,MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 24, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

US(1)