Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01631435
Brief Summary:
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Detailed Description:
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:
Visit 1; Screening visit
* Informed consent process
* screening for eligibility to participate in the study
* Inclusion/exclusion criteria
* Small bowel patency test
* Demographic data
* Pregnancy test
* General medical history
Visit 2; PillCam® Crohn's capsule ingestion
* PillCam® CD bowel preparation
* Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
* Ileocolonoscopy with intubation of terminal ileum
Follow up period (5-9 days following visit 2)
• CE Follow up telephone contac
Study:
NCT01631435
Study Brief:
Protocol Section:
NCT01631435