Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 5:14 AM
Study NCT ID:
NCT01624506
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2012-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study of Anti-Reflux Surgery
Sponsor:
Torax Medical Incorporated
Organization:
Study Overview
Official Title:
Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
Status:
COMPLETED
Status Verified Date:
2021-05
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 Anti-Reflux Surgical Study has been established to:
* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
* Track the clinical course of patients from pre-operative assessment to three years post-surgery
* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
* Track the clinical course of patients from pre-operative assessment to three years post-surgery
Detailed Description:
This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.
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?: