EndoClip for Dysphagia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC San Diego Health, La Jolla, CA
Dysphagia+14 More
EndoClip - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.

Eligible Conditions

  • Dysphagia
  • Anesthesia; Adverse Effect
  • Dysphonia
  • Sore-throat
  • Anesthesia Morbidity
  • Throat Disorders
  • Intubation; Complication
  • Anesthesia Intubation Complications
  • Throat; Wound
  • Anesthesia Complications
  • Throat Injury
  • Reaction; Anesthesia

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Baseline to 1 week after intervention

Week 1
Change in voice on a visual analog scale from 0 (no voice change) to 10 (most severe voice change)
Difficulty swallowing on a visual analog scale from 0 (no difficulty swallowing) to 10 (complete inability to swallow)
Difficulty talking on a visual analog scale from 0 (no difficulty talking) to 10 (complete inability to talk)
Pain in the mouth on a visual analog scale from 0 (no mouth pain) to 10 (worst possible mouth pain)
Pain in the neck/chest on a visual analog scale from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain)
Sore throat on a visual analog scale from 0 (no sore throat) to 10 (worst possible sore throat)

Trial Safety

Trial Design

2 Treatment Groups

No Clip
1 of 2
EndoClip
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

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

EndoClip
Device
Experimental Group · 1 Intervention: EndoClip · Intervention Types: Device
No ClipNoIntervention Group · 1 Intervention: No Clip · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 1 week after intervention
Closest Location: UC San Diego Health · La Jolla, CA
Photo of La Jolla 1Photo of La Jolla 2Photo of La Jolla 3
2019First Recorded Clinical Trial
1 TrialsResearching Dysphagia
3 CompletedClinical Trials

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,007 Previous Clinical Trials
1,793,064 Total Patients Enrolled
1 Trials studying Dysphagia
170 Patients Enrolled for Dysphagia
Andrew Vahabzadeh-Hagh, MDPrincipal InvestigatorUC San Diego Health

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.