Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01682265
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2012-09-05
Brief Title:
Stretta In Reflux Uncontrolled by IPP
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump IPP- The SIRUP Trial- Multicentric Randomized Double Blind Prospective Study
Status:
COMPLETED
Status Verified Date:
2019-01
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:
SIRUP
Brief Summary:
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump IPP patients
Detailed Description:
The study is over a period of 1 year After checking eligibility the patient will be randomised in double blind stretta procedure sham procedure Control visits will take place after 4 weeks on site 8 weeks by phone 12 weeks by phone 18 weekson site and 24 weekson siteDuring the 24 weeks visit the therapeutic success will be evaluated
In case of success endoscopic control will be performed and the patient will come back on site at week 36 and 48 end of study In case of therapeutic failure the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure The procedure will be scheduled between week 24 and week 27 The patient will come back for a visit on site at weeks 31 36 and 48 end of visit
In case of success endoscopic control will be performed and the patient will come back on site at week 36 and 48 end of study In case of therapeutic failure the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure The procedure will be scheduled between week 24 and week 27 The patient will come back for a visit on site at weeks 31 36 and 48 end of visit
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