Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing - Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031680

Enrollment

600

Registered

2018-04-01

Start date

2015-04-15

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

Medicine to use:Iopamidol(Oypalomin). Dosage form:Injection, light shielded, stored at room temperature. Method of administration:At the time of liquid swallowing evaluation, dilute 15 ml of Iopamid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Degradation of swallowing function is suspected by bedside evaluation during hospitalization or outpatient at our hospital, or evaluation of necessity of establishing gastrostomy in future.

Exclusion criteria

Exclusion criteria: Iodine allergy or serious thyroid disease

Design outcomes

Primary

Measure	Time frame
Safety: Within one week after examination in all cases the incidence of side effects (items below) 1.Nausea/itching feeling/rash/vomiting/hot feeling/dizziness/coughing/hypertension or hypotension/sneezing/palpitations/shivering/headache/hot flashes/shock/anaphylactoid symptoms/renal failure/acute respiratory distress syndrome/delirium/confusion/consciousness disturbance convulsive seizure/thrombocytopenia/liver dysfunction/ventricular fibrillation/skin disorders 2.Presence or absenceof to stored in the lung field and the incidence of respiratory failure in aspiration cases	—

Measure

Time frame

Safety: Within one week after examination in all cases the incidence of side effects (items below) 1.Nausea/itching feeling/rash/vomiting/hot feeling/dizziness/coughing/hypertension or hypotension/sneezing/palpitations/shivering/headache/hot flashes/shock/anaphylactoid symptoms/renal failure/acute respiratory distress syndrome/delirium/confusion/consciousness disturbance convulsive seizure/thrombocytopenia/liver dysfunction/ventricular fibrillation/skin disorders 2.Presence or absenceof to stored in the lung field and the incidence of respiratory failure in aspiration cases

—

Secondary

Measure	Time frame
Evaluation of swallowing function during examination	—

Countries

Japan

Contacts

Public ContactShinobu Tochimoto

St.Marianna University school of medicine Department of Rehabilitation

s-tochi@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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