Crohn's Disease Clinical Trial
Official title:
Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
| NCT number | NCT01793376 |
| Other study ID # | MA-208-1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2013 |
| Est. completion date | June 2016 |
| Verified date | July 2019 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Hypothesis This study is designed as an integral part of the development of a new CE score
for Crohn's disease.
The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated
CD score for SB involvement. In order to expand this score to the colon, this study will aim
to develop the colonic score and later on will be combined with the already established SB
score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a
retrospective study in which up to 30 videos of colon Crohn's disease subjects who have
undergone the Colon 2 CE procedure will be evaluated.
These cases will have evidence of large and / or small bowel Crohn's disease The chosen
videos will be marked for CD lesions by the site The de-identified marked videos will be
scored by 4 independent experienced endoscopists, blinded to the results of the standard
workup procedures, according to the colonic and CECDAIic new scores
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | June 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be included. Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The inter-observer variability of the new CD Colonic Score, between four reviewers in Crohn's Disease patients with large bowel involvement | 1 year |
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