NCT00178438

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

First QC Date

September 13, 2005

Last Update Submit

September 16, 2015

Conditions

Crohn's Disease

Keywords

capsule endoscopy in small bowel

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Capsule EndoscopyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Parvez S Mantry, MD

    University of Rochester Medical Center, Digestive and Liver Disease Unit

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2006

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

US(1)