Study of a Series of Patients Treated for Retrograde Cric... | NCT06174831

Studies
Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome

NCT06174831

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Deglutition Disorders

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 19, 2024Estimated

First Submitted Date

Oct 23, 2023

First Submission Date that Met QC Criteria

Dec 14, 2023

First Posted Date

Dec 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian DEBRY, MD, PhD	Contact	33 3 88 12 76 44		christian.debry@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided