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NCT02296528 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients
A NA study, sponsored by Peter Belafsky, MD.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT02296528: Clinical Trial NA study, sponsored by Peter Belafsky, MD.
NCT02296528 is a NA study that was terminated before completion, run by Peter Belafsky, MD. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296528, a NA study, was terminated before completion, sponsored by Peter Belafsky, MD.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to assist with the act of deglutition. The investigators have developed a biomedical device (Swallow Expansion Device, SED) that assists with swallowing by mechanically opening the upper esophageal sphincter and allowing food and liquid to safely enter the esophagus. The SED has proven safe in cadaver and live animal studies (Belafsky, 2010).
Primary Outcome
UES opening will be measured via fluoroscopy. A digital still image will be captured at the point of maximum UES opening with and without anterior traction of the SED. The software will be calibrated to the known length of the SED that is visible in the fluoroscopic image. The distance between the anterior and posterior pharyngo-esophageal segment at the point of maximum UES opening will be measured. If swallowing is improved and there is no aspiration, the patient will be taught how to coordina
Interventions
- DEVICE Swallowing Expansion Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-06 |
| Est. Completion | 2022-10-17 |
| Phase | NA |
Why NCT02296528 stopped before completion
NCT02296528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Swallowing Expansion Device is the first listed.
NCT02296528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02296528 about?
NCT02296528 is a clinical study titled "Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients". Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to assist with the act of deglutition. The investigators have developed ...
What is the current status of trial NCT02296528?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2014-06. Estimated completion is 2022-10-17.
What interventions are being tested in trial NCT02296528?
The interventions under investigation include: Swallowing Expansion Device (DEVICE).
Who is sponsoring clinical trial NCT02296528?
This trial is sponsored by Peter Belafsky, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02296528's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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