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Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

NCT02193802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-07-09

No results posted yet for this study

Summary

The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.

Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.

Conditions

Interventions

DEVICE

PillCam® COLON 2 and PillCam Crohn's capsules

Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure: Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion. Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Dr Arnaud Bourreille, MD · CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2021-12-30
Completion
2022-03-31

Countries

  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193802 on ClinicalTrials.gov