Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT06328556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction
Sponsor:
Copka Sonpashan
Organization:
Study Overview
Official Title:
The Impact of Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction Under Balloon Localization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.
Detailed Description:
The patient's long-term inadequate food intake leads to malnutrition, decreased quality of life, and impacts the prognosis of the disease. Currently, both domestically and internationally, treatment options for cricopharyngeal muscle dysfunction include balloon dilation technique, surgical incision, and botulinum toxin injection. Passive dilation with a balloon can easily cause mucosal edema and damage. Cricopharyngeal myotomy surgery often presents complications such as local infection, excessive bleeding, and local nerve damage. Botulinum toxin can alleviate muscle spasms and has been widely used in the treatment of hypertonic disorders \[3\]. Common injection localization methods include ultrasound, electromyography, and endoscopy. Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. Combining it with balloon fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.
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?: