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

Cosmo Technologies

Status: Completed

Conditions: Polyp and Adenoma Detection During Colonoscopy

Treatments: Device: oral tablet dye for detection of polyps during colonoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT01520337

2011-005694-23 (EudraCT Number)

CB-17-01/05

Details and patient eligibility

About

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

Full description

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

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

170 participants in 1 patient group

patients undergoing outpatient colonoscopy

Treatment:

Device: oral tablet dye for detection of polyps during colonoscopy