Status:
TERMINATED
Endomicroscopy in Ulcerative Colitis
Lead Sponsor:
PENTAX Europe GmbH
Collaborating Sponsors:
Johannes Gutenberg University Mainz
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance c...
Eligibility Criteria
Inclusion
- Written informed consent must be available before any trial-related procedures
- Male and female patients aged 18 years and older
- Clinically and histologically verified UC
- Duration or Colitis ulcerosa \>8 years (date of first diagnosis)
- Colitis Activity Index ≤ 8
- Activity index of Truelove and Witts: mild
- Ability of subject to understand character and individual consequences of clinical trial
- For women with childbearing potential, adequate contraception.
Exclusion
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time \<50% of control, Partial thromboplastin time \>50 s)
- Impaired renal function (Creatinine \>1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
- Active GI Bleeding
- Known allergy to methylene blue or fluorescein
- Participation in other clinical trials within the last 4 weeks
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00659867
Start Date
December 1 2008
End Date
September 1 2016
Last Update
September 27 2016
Active Locations (5)
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1
Charité Campus Benjamin Franklin, Medizinische Klinik I
Berlin, Germany, 12200
2
Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
Jena, Germany, 07740
3
Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
Mainz, Germany, 55101
4
Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
Crema, Italy, 26013