Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 4:45 PM
Study NCT ID:
NCT02315404
Status:
TERMINATED
Last Update Posted:
2018-06-25
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.
The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.
The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: