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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034681
Receipt No. 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

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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
Email 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
Email manyo@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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