NCT06174831

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

December 18, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 23, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

Deglutition DisordersDysphagiacricopharyngeus muscleCircular sphincterEsophagusBotulinum toxin

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion, an average of 2 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • Subject having expressed opposition to participating in the study,
  • Subject under judicial protection
  • Subject under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

December 18, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 19, 2024

Last Updated

December 18, 2023

Record last verified: 2023-10

Locations