Upper Esophageal SphincterNCT03598933
Cricopharyngeal Dysfunction in Adults
An observational study of Upper Esophageal Sphincter, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Esophageal Sphincter
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service ORL et chirurgie cervico-faciale
Strasbourg, 67098
Philippe Schultz, MD, PhD, 33 3 88 12 76 35, philippe.schultz@chru-strasbourg.fr
Philippe Schultz, MD, PhD
About this study
Official title: Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection
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.
- Conditions
- Upper Esophageal Sphincter
- Keywords
- Upper Esophageal Sphincter, botulinum toxin, Cricopharyngeal dysfunction, Cricopharyngeal botulinum toxin injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Deglutition Handicap Index
Measured: The period from January 1st, 2017 to December 31st, 2017 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Esophageal SphincterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Schultz, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598933
- Sponsor's protocol ID
- 7053
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection
- ClinicalTrials.gov ID
- NCT03598933
- Acronym / sponsor ID
- 7053
- Conditions
- Upper Esophageal Sphincter
- Keywords
- Upper Esophageal Sphincter, botulinum toxin, Cricopharyngeal dysfunction, Cricopharyngeal botulinum toxin injection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deglutition Handicap Index
Time frame: The period from January 1st, 2017 to December 31st, 2017 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Schultz, MD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Esophageal Sphincter, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Schultz, MD, PhD (33 3 88 12 76 35, philippe.schultz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deglutition Handicap Index (time frame: The period from January 1st, 2017 to December 31st, 2017 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.