Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00178438

Enrollment

Registered

2005-09-15

Start date

2005-06-30

Completion date

2006-06-30

Last updated

2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

capsule endoscopy in small bowel

Brief summary

The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.

Detailed description

Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.

Interventions

DEVICECapsule Endoscopy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* English speaking adult patients (\>18 years old) with known Crohn's disease

Exclusion criteria

* Severe medical or psychiatric co-morbidities * Active swallowing problems * Bowel obstruction * History of stricture or fistula * Pregnancy * Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy * Inability to consent * Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease

Design outcomes

Primary

Measure	Time frame
Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease	—

Secondary

Measure	Time frame
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026