UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of pleurodesis with 50% glucose solution in patients with inoperable spontaneous pneumothorax
Title of the study (Brief title)	Efficacy and safety of pleurodesis with 50% glucose solution
Region	Japan

Condition
Condition	Pneumothorax
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigates the efficacy and safety of pleurodesis with 50% glucose solution in patients with inoperable spontaneous pneumothorax.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effectiveness of pleurodesis with 50% glucose solution
Key secondary outcomes	Adverse events, blood glucose level

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pleurodesis with a 50% glucose solution
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) Patients with inoperable pneumothorax 2) Patients age 20<= 3) Patients who offer a documented agreement to the study
Key exclusion criteria	1) Uncontrollable diabetes 2) Unstable angina or myocardial infarction within 3 month 3) Pregnancy 4) Patients with lidocaine allergy 5) Bilateral uncontrollable pneumothorax 5) Decision of ineligibility by a physician
Target sample size	33

Research contact person
Name of lead principal investigator	Kazuyoshi Imaizumi
Organization	Fujita Health University School of Medicine
Division name	Division of Respiratory Medicine and Clinical Allergy
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL	0562-93-9241
Email	jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person	Teppei Yamaguchi
Organization	Fujita Health University School of Medicine
Division name	Division of Respiratory Medicine and Clinical Allergy
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL	0562-93-9241
Homepage URL
Email	yteppei@fujita-hu.ac.jp

Sponsor
Institute	Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 18 Day
Last modified on	2017 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018265