Treatment for Oropharyngeal Dysphagia

University of California Department of Otolaryngology, Sacramento, CA
Oropharyngeal Dysphagia+1 More Conditions
Eligibility
18+
All Sexes

Study Summary

This trial will test whether the Swallow Expansion Device is safe for humans.

Eligible Conditions
  • Oropharyngeal Dysphagia
  • Swallowing Difficulty

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Before implantation, 2 months and 2 years post implantation

Year 2
Change in Penetration Aspiration Scale (PAS)
Change in Upper Esophageal Sphincter (UES) Opening

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

0 Treatment Group

1 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: before implantation, 2 months and 2 years post implantation

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)

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have difficulty swallowing and have tried therapy for more than 3 months, but it hasn't helped.
You can think clearly and have a score of at least 6 on a test that measures mental ability.
You have normal hand movement and coordination for your age and gender, as tested by a Block and Box Test (BBT).
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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