Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356025
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-20
Brief Title:
Botulinum Toxin Injection in the UES for R-CPD
Sponsor:
AZ Delta
Organization:
AZ Delta
Study Overview
Official Title:
Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction a Prospective Double Blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
BOTUS R-CPD
Brief Summary:
The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind placebo controlled study Investigators want to assess the effect on symptoms short term 1-20 weeks after BT injection and long term 48 weeks after BT injection
This is a prospective double-blind randomized placebo-controlled study Questionnaires assessing symptoms will be filled out on several occasions At 20 weeks a reassessment of symptoms will be done without unblinding patients or investigator Failures to BT or placebo defined as no clinical improvement or improvement less than 50 will get the chance to receive a second procedure with active treatment BT in open label
This is a prospective double-blind randomized placebo-controlled study Questionnaires assessing symptoms will be filled out on several occasions At 20 weeks a reassessment of symptoms will be done without unblinding patients or investigator Failures to BT or placebo defined as no clinical improvement or improvement less than 50 will get the chance to receive a second procedure with active treatment BT in open label
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-512546-42 | EUDRACT_NUMBER | None | None |