NCT01520337

Brief Summary

Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

Trial Health

100
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

January 25, 2012

Last Update Submit

February 10, 2014

Conditions

Polyp and Adenoma Detection During Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Polyp and adenoma detection rate

    1 day

Study Arms (1)

patients undergoing outpatient colonoscopy

Device: oral tablet dye for detection of polyps during colonoscopy

Interventions

oral tablet dye for detection of polyps during colonoscopyDEVICE

oral tablet dye for improved detection of

patients undergoing outpatient colonoscopy

Eligibility Criteria

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

patients scheduled for screening or surveillance colonoscopy.

You may qualify if:

  • Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

You may not qualify if:

  • Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

mucosal biopsy

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

February 11, 2014

Record last verified: 2014-02