UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A novel,disposable ultra-fine endoscope for non-invasive,close examination of the peritoneum in patients undergoing peritoneal dialysis
Title of the study (Brief title)	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	Yusuke Suzuki
Organization	Juntendo University Hospital
Division name	Department of Nephrology and Hypertension
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	yusuke@juntendo.ac.jp

Public contact
Name of contact person	Makoto Mano
Organization	Juntendo University Hospital
Division name	Department of Nephrology and Hypertension
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	safety:No adverse events
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