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Evaluation of efficacy and safety of Visipaque in videofluoroscopic swallowing study

Evaluation of efficacy and safety of Visipaque (nonionic water-soluble iodine contrast agent) in videofluoroscopic swallowing study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240040
Enrollment
20
Registered
2024-07-26
Start date
2025-02-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Interventions

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 invest

Sponsors

Konishi Masaru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria

Exclusion criteria: 1. 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 untreated by a medical doctor 14. Patients with arteriosclerosis 15. Patients with diabetes mellitus complicated by renal dysfunction 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

Design outcomes

Primary

MeasureTime frame
Visibility of videofluoroscopic swallowing study images

Secondary

MeasureTime frame
Adverse 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

Contacts

Public ContactMasaru Konishi

Hiroshima University Hospital

mkonishi@hiroshima-u.ac.jp+81-822575693

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Aug 3, 2026