NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061240040

Registered date:26/07/2024

Evaluation of efficacy and safety of Visipaque in videofluoroscopic swallowing study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedDysphagia
Date of first enrollment26/07/2024
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)After obtaining informed consent for this study, enrollment will be made, and videofluoroscopic swallowing study using Visipaque as a contrast agent will be performed. After the examination, an investigation of adverse events will be conducted until one month after the examination is performed. Taste evaluation of Visipaque will be performed at the end of the examination. The visibility of the Visipaque and Barytester (previous examinations) images will be evaluated on the images taken, respectively.

Outcome(s)

Primary OutcomeVisibility of videofluoroscopic swallowing study images
Secondary OutcomeAdverse effects Gastrointestinal: diarrhea, nausea, vomiting, abdominal pain, abdominal discomfort, dyspepsia, anal pain and bleeding, constipation, renal failure, Gastrointestinal perforation, intestinal obstruction, peritonitis Hypersensitivity: itching, urticaria, rash, erythema, fever, shock, anaphylaxis Respiratory: aspiration pneumonia, pulmonary edema Others: ventricular fibrillation, seizure Taste evaluation Aspiration Evaluation of image density

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients who has previously undergone the videofluoroscopic swallowing study with Barytester at Hiroshima University Hospital 2. Patients with dysphagia who are at least 18 years of age at the time of informed consent 3. Patients with dysphagia who are eligible for an investigation of adverse effects until one month after videofluoroscopic swallowing study 4. Patients with dysphagia who give written informed consent to participate in this study
Exclude criteria1. Patients with iodine allergy 2. Patients with severe thyroid disease 3. Patients with serious renal disease 4. Patients with bronchial asthma 5. Patients with serious cardiac disorders 6. Patients with macroglobulinemia 7. Patients with multiple myeloma 8. Patients with tetany 9. Patients with or suspected of having pheochromocytoma 10. Patients with bronchial asthma, rash, urticaria, or other allergic reactions in themselves, their parents, or their siblings 11. Patients with a history of drug hypersensitivity 12. Patients with dehydration 13. Patients with hypertension 14. Patients with arteriosclerosis 15. Patients with diabetes mellitus 16. Patients with acute pancreatitis 17. Patients with biliary tract infection 18. Patients with severe hepatic disorder 19. Patients with a history of gastrointestinal tract disease or surgery 20. Women who are pregnant or may become pregnant, women who are breastfeeding, or women who wish to have a baby 21. Patients who are participating or intend to participate in other clinical studies while participating in this study 22. If participation in the research would not be in the best interest of the research subject or would interfere with evaluation specific to the clinical research protocol 23. Any principal investigator or other employee of the institution who is directly involved in this or other clinical research, or any family member of such an employee or principal investigator

Related Information

Contact

Public contact
Name Masaru Konishi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima Hiroshima Japan 7348553
Telephone +81-822575693
E-mail mkonishi@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Masaru Konishi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima Hiroshima Japan 7348553
Telephone +81-822575693
E-mail mkonishi@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital