UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061749 |
|---|---|
| Receipt number | R000070663 |
| Scientific Title | Validation of Homology Between High-Resolution Esophageal Manometry and 12-Direction Circumferential Ultrasonographic Kinetic Analysis of the Upper Esophageal Sphincter Using ARIETTA 850 DeepInsight, and Its Clinical Application for the Early Detection of Early-Stage Dysphagia in Parkinson's Disease |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/05/31 10:09:38 |
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Basic information
Public title
A Study on a New Ultrasound Test for Throat Muscle Movement: Application for the early detection of Swallowing Problem in Parkinson's Disease
Acronym
The VALID-PD Study
Scientific Title
Validation of Homology Between High-Resolution Esophageal Manometry and 12-Direction Circumferential Ultrasonographic Kinetic Analysis of the Upper Esophageal Sphincter Using ARIETTA 850 DeepInsight, and Its Clinical Application for the Early Detection of Early-Stage Dysphagia in Parkinson's Disease
Scientific Title:Acronym
The VALID-PD Study
Region
| Japan |
Condition
Condition
1. Patients with suspected esophageal motility disorders who are scheduled to undergo high-resolution esophageal manometry as part of routine clinical care.
2. Patients diagnosed with Parkinson's disease (PD).
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Establishment of a non-invasive evaluation method through the validation of homology between HRM as the standard reference and novel ultrasonographic parameters.
Basic objectives2
Others
Basic objectives -Others
2. Identification of factors associated with subclinical and early-stage swallowing kinetic abnormalities in PD.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Elucidation of Homology and Identification of Limitations Between Existing Parameters of High-Resolution Esophageal Manometry (HRM) and 12-Direction Kinetic Parameters of Transcervical Ultrasonography During 5 mL Swallows of Oral Rehydration Solution (OS-1) in Patients Without Clinically Evident Upper Esophageal Sphincter (UES) Dysfunction.
Key secondary outcomes
Comparison of 12-Direction Esophageal Wall Motility and Radial Strain Parameters Using Transcervical Ultrasonography Between PD Patients with Mild Swallowing Discomfort and Asymptomatic PD Patients, All with No Manifest Dysphagia: Identification of Factors Involved in the Onset of Early-Stage Dysphagia.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of either sex, aged 20 to 85 years, who have provided written informed consent to participate in this study, and who meet either of the following criteria:
[Study 1] Patients with suspected esophageal motility disorders who undergo HRM as part of routine clinical care.
[Study 2] Patients diagnosed with PD.
Key exclusion criteria
[Exclusion Criteria Common to All Groups]
(1) Patients with a history of aspiration pneumonia.
(2) Patients with fewer than 3 swallows in 30 seconds on the Repetitive Saliva Swallowing Test (RSST).
(3) Patients with organic lesions, such as esophageal stricture, detected by upper gastrointestinal endoscopy.
(4) Other patients judged by the attending physician to be ineligible for entry into this study.
[Exclusion Criteria Applicable Only to Study 1]
(5) Patients with upper esophageal sphincter (UES) dysfunction detected by HRM.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Laboratory Medicine, Kawasaki Medical School
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
+81-86-225-2111
n_manabe@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Laboratory Medicine, Kawasaki Medi
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
+81-86-225-2111
Homepage URL
n_manabe@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Grant Division, Department of Research Support, Kawasaki Medical School
Address
577 Matsushima, Okayama
Tel
086-462-1111
kenkyu-idai1@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, cross-sectional, observational study with no interventions beyond routine clinical care. After obtaining written informed consent, clinical backgrounds (age, sex, chief complaint, PD duration/severity, etc.) and the presence of subjective symptoms will be collected and observed from medical records. Regarding observation during testing, in [Study 1], routine high-resolution manometry (HRM) will be followed by a completely non-invasive transcervical ultrasound examination (ARIETTA 850 DeepInsight) to measure UES 12-directional kinetics and Radial Strain parameters. In [Study 2], only the ultrasound examination will be performed. Furthermore, during and immediately after the examinations, the attending physician will strictly monitor for adverse events such as aspiration or choking in real time, and evaluate subjective distress (tolerability) using a Visual Analogue Scale (VAS) upon completion, thereby ensuring both the safety and objectivity of the observation.
Management information
Registered date
| 2026 | Year | 05 | Month | 31 | Day |
Last modified on
| 2026 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070663
