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Cricopharyngeal Dysfunction in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598933
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.

Condition or disease
Upper Esophageal Sphincter

Study Design
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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Deglutition Handicap Index [ Time Frame: The period from January 1st, 2017 to December 31st, 2017 will be examined ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
- Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.
Criteria

Inclusion Criteria:

  • Man or woman whose age older than 18 years
  • Dysphagia with solids and / or liquids
  • Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry
  • Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.
  • Subject who has consented to the use of his data from his medical file for the purpose of this research

Exclusion Criteria:

  • Myotomy in the first place
  • Refusal of the subject to participate in the study
  • Subject under the protection of justice
  • Subject under guardianship or curatorship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598933


Contacts
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Contact: Philippe Schultz, MD, PhD 33 3 88 12 76 35 philippe.schultz@chru-strasbourg.fr
Contact: Sophie Gorostis, MD 33 3 88 12 76 35 sophie.gorostis@chru-strasbourg.fr

Locations
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France
Service ORL et chirurgie cervico-faciale Recruiting
Strasbourg, France, 67098
Contact: Philippe Schultz, MD, PhD    33 3 88 12 76 35    philippe.schultz@chru-strasbourg.fr   
Principal Investigator: Philippe Schultz, MD, PhD         
Sub-Investigator: Sophie Gorostis, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Philippe Schultz, MD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03598933    
Other Study ID Numbers: 7053
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Upper Esophageal Sphincter
botulinum toxin
Cricopharyngeal dysfunction
Cricopharyngeal botulinum toxin injection