Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398203
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2006-11-08
Brief Title:
Safety and Efficacy of Using NaviAid BGE Device Balloon Guided Endoscopy For Endoscopic Diagnosis and Treatment
Sponsor:
Smart Medical Systems Ltd
Organization:
Smart Medical Systems Ltd
Study Overview
Official Title:
Safety and Efficacy of Using NaviAid BGE Device Balloon Guided Endoscopy For Endoscopic Diagnosis and Treatment
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
To assess the efficacy of the NaviAid BGE Device while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine
Detailed Description:
Smart Medical Systems has developed the NaviAid Balloon Guided Endoscopy BGE Device an innovative medical device for the GI tract diagnosis and treatment The Balloon Guided Endoscopy BGE is a procedure intended for the examination of the small intestine which utilizes the NaviAid BGE Device in conjunction with a standard endoscope
The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid BGE device in the examination of the small intestine in conjunction with a standard endoscope
Efficacy will be assessed by comparing NaviAid BGE Device performances to a reference Enteroscopy procedure
The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid BGE device in the examination of the small intestine in conjunction with a standard endoscope
Efficacy will be assessed by comparing NaviAid BGE Device performances to a reference Enteroscopy procedure
Study Oversight
Has Oversight DMC:
None
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?:
None