Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT01576120
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2012-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RD-207
Brief Summary:
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
Detailed Description:
1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients.
Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
3. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
3. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: