Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blue

Conditions: Patients affecetd by Long standing ulcerative colitis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2011-005693-36-IT

Lead Sponsor: COSMO TECHNOLOGIES LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

male and Female patients, aged more than 18 years, affected by Long standing ulcerative colitis for more than 8 years. informed consent signed.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Pregnancy, allergies, diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulosis with diverticulitis, heart failure, serious cardiovascular disease, severe liver failure, end-stage renal insufficiency. Presence of intraepithelial tumors. coagulation alterations.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: none;Primary end point(s): Intraepithelial neoplasia detection rate.;Timepoint(s) of evaluation of this end point: During the Colonoscopy;Main Objective: Detection rate evaluation of intraepithelial tumors

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Extent and severity of the inflamed mucosa. <br>Mucosal staining efficacy. <br>Bowel cleansing quality.<br>Collection data of safety.;Timepoint(s) of evaluation of this end point: During Colonoscopy