NCT01914445

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

July 31, 2013

Last Update Submit

July 31, 2013

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    One hour

Study Arms (1)

Indigo Carmine

EXPERIMENTAL

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

Drug: Indigo Carmine

Interventions

Indigo CarmineDRUG

Oral administration of Indigo Carmine prior to colonoscopy

Also known as: FD&C Blue 2
Indigo Carmine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Indigo Carmine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vitaly Verzhbitsky, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitaly Verzhbitsky, MD

CONTACT

972-505703554vitalyv@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

IL(1)