Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01207804
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2010-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Trial of ValenTx Endo Bypass System
Sponsor:
ValenTx, Inc.
Organization:
Study Overview
Official Title:
A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.
Detailed Description:
This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.
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?: