Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy

Cosmo Technologies

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Device: oral delivery mucosal stain

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520324

CB-17-01/04

Details and patient eligibility

About

Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• endoscopically verified UC signed written informed consent

Exclusion criteria

• Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Patients with UC undergoing colonoscopy

Experimental group

Treatment:

Device: oral delivery mucosal stain