Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621979
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEE-RGOIC
Brief Summary:
The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass with complete objective evaluation of reflux
Detailed Description:
The FEEamp RGOIC trial is a single-center ambispective interventional non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis
The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega
The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux resistant to medical treatment and requiring surgery
The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega
The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux resistant to medical treatment and requiring surgery
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