Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00487396
• Date of registration: 14/06/2007
• Prospective Registration: Yes
• Primary sponsor: Medtronic - MITG
• Public title: Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease MA-51
• Scientific title: Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
• Date of first enrolment: September 2007
• Target sample size: 98
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00487396
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Canada, Israel, Sweden, United States

Contacts

• Name: Jonathan Leighton, MD
• Affiliation: Mayo Clinic

• Name: Peter Legnani, MD
• Affiliation: Private Practice New York, New York

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients ages 10-65 years, inclusive

- Patient suffers from either

- diarrhea for more than 6 weeks and less than 3 years and/or

- abdominal pain for more than 6 weeks and less than 3 years and/or

- extra-luminal manifestations of IBD including: erythema nodosum, pyoderma
gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis

- Patient suffers from at least one of the symptoms / lab abnormalities listed
below:

- Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal
lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment

- Unexplained anemia (less than normal limits) within 3 months prior to
enrollment

- Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment

- Positive ASCA within 3 months of enrollment

- Abnormal white blood cell scan with in 3 months of enrollment

- Stool negative for O&P (C&S) within 3 months of enrollment

- Recurrent Fevers

- Unexplained weight loss, failure to thrive in children

- Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT
positive.

- Chronic perianal disease (fistula, fissure, peri-rectal abscess)

- Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not
conclusively diagnostic for IBD

- Patient is indicated for Ileo-Colonoscopy

- Patient or legal guardian agrees to sign consent form

Exclusion criteria:

- Indeterminate Colitis where the purpose is only to make a definitive diagnosis and
where the inclusion criteria are not otherwise met

- Known intestinal obstruction or current obstructive symptoms, such as severe abdominal
pain with accompanying nausea or vomiting.

- Definite long stricture seen on radiological exam.

- Suspected GI stricture, followed by agile™ study that could not prove patency of the
GI tract.

- Known history of small bowel Crohn's Disease

- Current treatment for active IBD

- Positive Anti-tTG or anti-endomysial antibody

- Any of the following work-up within 1 year of study entry: Capsule Endoscopy,
Colonoscopy and Upper GI/SBFT.

- Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during
the 4 weeks preceding enrollment

- Patient is pregnant



Age minimum: 10 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Device: Capsule Endoscopy

Primary Outcome(s)

Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT) [Time Frame: four months from enrollment]

Secondary Outcome(s)

Diagnostic Yield (CE vs. SBFT) [Time Frame: four months from enrollment]

Diagnostic Yield (CE vs. IC) [Time Frame: four months from enrollment]

Secondary ID(s)

MA-51

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/05/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00487396