Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT06328556
Eligibility Criteria:
Inclusion Criteria:
* Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction of the cricopharyngeal muscle;
* No significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased FOIS);
* Presence of swallowing initiation, with VFSS showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the C3 vertebral body;
* Stable vital signs, alert consciousness, and cooperation with treatment;
Exclusion Criteria:
* Patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases;
* Abnormalities in the pharynx and larynx structures;
* Patients with malignant tumors;
* Patients with infections or wounds at the injection site;
* Patients allergic to botulinum toxin; Patients with bleeding tendencies or coagulation disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06328556
Study Brief:
Protocol Section:
NCT06328556