UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004111 |
|---|---|
| Receipt number | R000004945 |
| Scientific Title | Monitoring gastresophageal reflux in patients who underwent esophagectomy with gastric tube reconstruction using the Bravo wireless system |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2015/12/14 00:14:03 |
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Basic information
Public title
Monitoring gastresophageal reflux in patients who underwent esophagectomy with gastric tube reconstruction using the Bravo wireless system
Acronym
Monitoring gastrsophageal reflux in the remnant esophagus using the pH monitoring wireless system
Scientific Title
Monitoring gastresophageal reflux in patients who underwent esophagectomy with gastric tube reconstruction using the Bravo wireless system
Scientific Title:Acronym
Monitoring gastrsophageal reflux in the remnant esophagus using the pH monitoring wireless system
Region
| Japan |
Condition
Condition
patients with no recurrence, who underwent esophagectomy for esophageal cancer with gastric tube reconstruction and can take orally
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety, efficacy, and usufulness of the wireless pH monitoring system for evauluating the gastroesophageal reflux in the remnant esophagus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
pH monitoring in the remnant esophagus after esophagectomy using the wireless pH monitoring system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who underwent esophagectomy with gastric tube for esophageal cancer
2. be able to take orally
3. with no recurrence
4. written informed consent
Key exclusion criteria
1. with active other cancer
2. pacemakers or implantable cardiac
defibrillators
3. bleeding diathesis
4. strictures, obstructions
5. severe varices esophagitis
6. severe esophagitis
7. severe liver/kidney/heart/lung disorder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamasaki Makoto |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6878-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyazaki Yasuhiro |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004945
