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Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Indigo Carmine
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from Inflammatory Bowel Disease
  • Patients under surveillance for Disease-Associated Lesions and Masses (DALM)

Exclusion Criteria:

  • All others

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indigo Carmine

Arm Description

Indigo Carmine (2 mg per kilo) and 2nd half of PEG dose will be orally administered to patients prior to colonoscopy.

Outcomes

Primary Outcome Measures

Efficacy of Indigo Carmine during oral administration
The efficacy of Indigo Carmine in staining tissues to better characterize, delineate, and highlight the gastrointestinal mucosa will be determined during the colonoscopic examination. Biopsies will be taken from suspicious lesions.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2013
Last Updated
July 31, 2013
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01914445
Brief Title
Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indigo Carmine
Arm Type
Experimental
Arm Description
Indigo Carmine (2 mg per kilo) and 2nd half of PEG dose will be orally administered to patients prior to colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Indigo Carmine
Other Intervention Name(s)
FD&C Blue 2
Intervention Description
Oral administration of Indigo Carmine prior to colonoscopy
Primary Outcome Measure Information:
Title
Efficacy of Indigo Carmine during oral administration
Description
The efficacy of Indigo Carmine in staining tissues to better characterize, delineate, and highlight the gastrointestinal mucosa will be determined during the colonoscopic examination. Biopsies will be taken from suspicious lesions.
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from Inflammatory Bowel Disease Patients under surveillance for Disease-Associated Lesions and Masses (DALM) Exclusion Criteria: All others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitaly Verzhbitsky, MD
Phone
972-505703554
Email
vitalyv@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitaly Verzhbitsky, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitaly Verzhbitsky, MD

12. IPD Sharing Statement

Learn more about this trial

Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine

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