Videofluoroscopic Swallowing Study (VFSS) (NCT03387267) | Clinical Trial Compass
TerminatedNot Applicable
Videofluoroscopic Swallowing Study (VFSS)
Stopped: Study terminated due to futility
United States, Finland452 participantsStarted 2017-10-24
Plain-language summary
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult subjects (over 18 years of age)
* Hospitalized subjects or outpatients identified as at risk of oropharyngeal dysphagia (using local practice)
* Patients belong to one of the following groups:
* Stroke patients
* Traumatic brain injury
* Parkinson Disease (PD) stage III or higher by Hoehn and Yahr scale
* Multiple Sclerosis (MS) above age 60
* Alzheimer Disease (AD) or other Dementia
* Other medically complex hospitalized subjects not covered by the exclusion criteria and identified as at risk of dysphagia
* Subject is able to comply with VFSS protocol to diagnose dysphagia
* Subject is able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained / or a consultee has consented on he subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
Exclusion Criteria:
* Presence of nasogastric / nasojejunal feeding tube at the time of VFSS test
* Currently has a tracheostomy, or has had a tracheostomy in the past year
* Had posterior cervical spine surgery and/or carotid endarterectomy in the last 6 months
* Had significant surgery to the mouth and/or neck, for example resection for oral or pharyngeal cancer, radical neck dissection, anterior cervical spine surgery, orofacial reconstruction, pharyngoplasty, or thyroidectomy. Routine tonsillectomy and/or adenoidectomy are not excluded
* Experienced non-surgical trauma to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for THIN-Ba
Timeframe: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.