Deglutition DisordersR-CPD-SyndromeNCT06174831
Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome
An observational study of Deglutition Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp. It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 19 Jan 2024
- 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: Major Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
Who may be able to join
- Major subject (≥18 years old)
- Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
- Subject not opposing the reuse of their data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study,
- Subject under judicial protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Strasbourg, 67091
Christian DEBRY, MD, PhD, 33 3 88 12 76 44, christian.debry@chru-strasbourg.fr
Christian DEBRY, MD, PhD
About this study
R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp.
It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown.
This study concerns a series of patients treated at the University Hospitals of Strasbourg for a syndrome of retrograde dysfunction of the cricopharyngeus muscle having been treated by injection of botulinum toxin into the cricopharyngeus muscle.
- Conditions
- Deglutition Disorders
- Keywords
- Deglutition Disorders, Dysphagia, cricopharyngeus muscle, Circular sphincter, Esophagus, Botulinum toxin
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the characteristics of a series of patients treated for dysphagia syndrome
Retrospective study of medical files of patients treated in HUS between January 1, 2022 and December 31, 2022
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174831
- Sponsor's protocol ID
- 8782
- Acronym
- R-CPD-Syndrome
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 18 Dec 2023
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome
- ClinicalTrials.gov ID
- NCT06174831
- Acronym / sponsor ID
- R-CPD-Syndrome / 8782
- Conditions
- Deglutition Disorders
- Keywords
- Deglutition Disorders, Dysphagia, cricopharyngeus muscle, Circular sphincter, Esophagus, Botulinum toxin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 18 Dec 2023 (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.
R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp.
It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown.
This study concerns a series of patients treated at the University Hospitals of Strasbourg for a syndrome of retrograde dysfunction of the cricopharyngeus muscle having been treated by injection of botulinum toxin into the cricopharyngeus muscle.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
- Subject not opposing the reuse of their data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study,
- Subject under judicial protection
- 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
Retrospective description of the characteristics of a series of patients treated for dysphagia syndrome
Time frame: Through study completion, an average of 2 months
Retrospective study of medical files of patients treated in HUS between January 1, 2022 and December 31, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
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 Deglutition Disorders, 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 3 inclusion and 3 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 18 Dec 2023. 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 Christian DEBRY, MD, PhD (33 3 88 12 76 44, christian.debry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the characteristics of a series of patients treated for dysphagia syndrome (time frame: Through study completion, an average of 2 months). 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 18 Dec 2023.