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Swallowing Assist Device
Swallowing Expansion Device for Oropharyngeal Dysphagia
N/A
Waitlist Available
Led By Peter Belafsky, MD PhD
Research Sponsored by Peter Belafsky, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before implantation, 2 months and 2 years post implantation
Awards & highlights
Study Summary
This trial will test whether the Swallow Expansion Device is safe for humans.
Eligible Conditions
- Oropharyngeal Dysphagia
- Swallowing Difficulty
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before implantation, 2 months and 2 years post implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before implantation, 2 months and 2 years post implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Upper Esophageal Sphincter (UES) Opening
Secondary outcome measures
Change in Penetration Aspiration Scale (PAS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Swallowing Expansion DeviceExperimental Treatment1 Intervention
Titanium swallowing expansion device
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Who is running the clinical trial?
Peter Belafsky, MDLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Peter Belafsky, MD PhDPrincipal Investigator - University of California, Davis
Shriners Hospitals for Children-Northern California, University of California-Davis Medical Center
Tulane University School Of Medicine (Medical School)
Tulane University School Of Medicine (Residency)
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