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Search / Trial NCT03368079

Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 4, 2017

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Dysphagia Oropharyngeal Dysphagia Video Fluoroscopic Swallowing Exam (Vfse)

ClinConnect Summary

This clinical trial is studying a new method to help patients with oropharyngeal dysphagia, a condition where swallowing is difficult and can lead to food or liquid entering the airway (aspiration). Researchers want to see if using a device that creates negative pressure suction in the throat can reduce the amount of aspiration during a special swallowing test called a Video Fluoroscopic Swallowing Exam (VFSE). This study is currently looking for participants who are between 65 and 74 years old, have a gastrostomy tube (a tube that helps with feeding), and have already tried other treatments without success.

If you or a loved one is eligible, you can expect to undergo a swallowing test while using the suction device to see if it helps improve safety during swallowing. However, this study cannot accept individuals with certain conditions, such as severe throat strictures or current cancer. The goal is to find out if this new technique can help those who struggle with swallowing and reduce the risk of aspiration, ultimately improving their quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with videofluoroscopic evidence of aspiration with Rosenbek Penetration Aspiration Scale (PAS) greater than 5 for all tested food consistencies
  • Gastrostomy tube dependence
  • Exhaustion of conventional treatment options (physical, medical, and surgical therapies)
  • Exclusion Criteria:
  • Complete PES stricture
  • Inability to follow commands
  • Current malignant disease
  • No gastrostomy tube present
  • Less than two years of cancer-free survival (if applicable)
  • Vulnerable populations: adults unable to consent, pregnant women, and prisoners

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Sacramento, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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