UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011464 |
|---|---|
| Receipt number | R000013415 |
| Scientific Title | Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system |
| Date of disclosure of the study information | 2013/08/13 |
| Last modified on | 2022/05/24 20:58:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system
Acronym
Comparison of values obtained with two high-resolution manometry systems
Scientific Title
Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system
Scientific Title:Acronym
Comparison of values obtained with two high-resolution manometry systems
Region
| Japan |
Condition
Condition
Asymptomatic volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare values obtained with a Japanese HRM system and an American HRM system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in integrated relaxation pressure values obtained with two HRM systems
Key secondary outcomes
Differences in distal contractile integral, contractile front velocity, intra-bolus pressure and distal latency values obtained with two HRM systems
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Esophageal manometry will be performed with an American high resolusion manometry system (HRM) and then will be performed with a Japanese HRM again.
Interventions/Control_2
Esophageal manometry will be performed with a Japanese high resolusion manometry system (HRM) and then will be performed with an American HRM again.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Asymptomatic subjects
Key exclusion criteria
Previous operations in upper GI tract or nasal cavity
Patients receiving medication for symptoms related to esophageal diseases such as heartburn or dysphagia
Patients receiving medication that may affect GI motility
Patients with diseases that may affect GI motility, such as diabetes mellitus, collagen diseases and neuromuscular diseases
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Motoyasu |
| Middle name | |
| Last name | Kusano |
Organization
Gunma University Hospital
Division name
Department of Endoscopy and Endoscopic surgery
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
mkusano@showa.gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
Homepage URL
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital, Department of Endoscopy and Endoscopic surgery
Institute
Department
Personal name
Funding Source
Organization
Star Medical, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Medical School Chiba Hokusoh Hospital
National Hospital Organization Numata National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8137
shikokuri@gunma-u.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
群馬大学医学部附属病院(群馬県)、日本医科大学千葉北総病院(千葉県)、独立行政法人国立病院機構沼田病院(群馬県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/25271562/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/25271562/
Number of participants that the trial has enrolled
103
Results
The values of all parameters, except CFV, measured by the Starlet were significantly higher than those obtained by the ManoScan.
Results date posted
| 2022 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Asymptomatic volunteer
Participant flow
Volunteers were recruited with advertisement.
Adverse events
There was no severe adverse event.
One subject could tolerate the first esophageal manom-etry by the Starlet, but she preferred not to receive thesecond manometry.
Outcome measures
The manometric parameter values between ManoScan and a new system with a Unisensor catheter (Starlet) in the same subjects were compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013415
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
