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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and before implantation, 2 months and 2 years post implantation for reporting.

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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Find a Location

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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate tally of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that the study, posted on June 1st 2014 and recently modified on September 1st 2022, is actively seeking participants. 5 people are needed to be recruited from a single site for this research trial."

Answered by AI

Has the enrollment phase of this clinical trial begun?

"According to the data featured on clinicaltrials.gov, this clinical trial is still searching for participants. The initial announcement was made June 1st 2014 and it has been updated as recently as September 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients

Peter Belafsky, MD 2014. "Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02296528.