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Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01520337
Enrollment
170
Registered
2012-01-27
Start date
2012-01-31
Completion date
2013-10-31
Last updated
2014-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyp and Adenoma Detection During Colonoscopy

Brief summary

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

Detailed description

Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

Interventions

DEVICEoral tablet dye for detection of polyps during colonoscopy

oral tablet dye for improved detection of

Sponsors

Cosmo Technologies Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Polyp and adenoma detection rate1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026