UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034681 |
|---|---|
| Receipt number | R000039499 |
| Scientific Title | A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2018/10/29 12:09:20 |
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Basic information
Public title
A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis
Acronym
A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis
Scientific Title
A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis
Scientific Title:Acronym
A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis
Region
| Japan |
Condition
Condition
Peritoneal Dialysis related complications
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the efficacy and safety of this peritoneal dialysis patient using this investigational device.
Regarding the effectiveness, it has been confirmed in nonclinical studies that the observation performance required for this investigational device is satisfied. However, as it is not possible to extrapolate the results of nonclinical studies on the effects on humans under no anesthesia, the objective of this clinical trial is to examine mainly the safety in humans.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficiency evaluation item
Observation of lumen of peritoneal dialysis catheter
Observation of peritoneal dialysis catheter abdominal side tip
Intraperitoneal observation
Safety Evaluation Items
Pain during endoscope operation
Intra-abdominal bleeding after bending of endoscope and bleeding into drainage
Peritonitis signs
Other adverse events
Key secondary outcomes
Safety after endoscopic examination
Abdominal pain
Bleeding of peritoneal dialysis drainage
Peritonitis signs
Signs of infection in the exit area or subcutaneous tunnel
Abnormality in specimen inspection
Other adverse events
Operability of clinical trial equipment
Smoothness to insertion, operation and removal of curved guide catheter
Smoothness to insertion and removal of the endoscope
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of disposable ultra-fine endoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Stable peritoneal dialysis patients (including those who are concurrently using hemodialysis) who have stable dialysis management in outpatients and do not have a history of hospitalization within a month,
2.Patients who have consented to participate in clinical trials from the person in writing
3.Patients who are more than 20 patients at the time of consent acquisition
Key exclusion criteria
1.Patients who have not passed 3 months or more after peritoneal dialysis introduction
2.Patients with severe heart disease
3.During pregnancy at registration, during lactation, patients who wish to become pregnant during the trial observation period of this study
4.Patients participating in clinical research that may affect this trial at the time of acquisition of clinical trial consent
5.Other patients judged inappropriate by investigators or clinical trial doctors
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Suzuki |
Organization
Juntendo University Hospital
Division name
Department of Nephrology and Hypertension
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yusuke@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Mano |
Organization
Juntendo University Hospital
Division name
Department of Nephrology and Hypertension
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
manyo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
Jikei University Hospital
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
順天堂大学医学部附属順天堂医院(東京都)
東京慈恵会医科大学附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 31 | 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
safety:No adverse events
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
| 2017 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039499
