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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029236
Receipt No. R000033170
Scientific Title Prospective study on safety and efficacy of thoracic catheter with balloon for patients undergoing pulmonary resection
Date of disclosure of the study information 2018/01/01
Last modified on 2019/03/23

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Basic information
Public title Prospective study on safety and efficacy of thoracic catheter with balloon for patients undergoing pulmonary resection
Acronym SStube study
Scientific Title Prospective study on safety and efficacy of thoracic catheter with balloon for patients undergoing pulmonary resection
Scientific Title:Acronym SStube study
Region
Japan

Condition
Condition Spontaneous pneumothorax
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate whether the pain is reduced by using a thoracic catheter with a balloon at the tip for a patient undergoing pulmonary resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS (Numerical Rating Scale) at POD1.
Key secondary outcomes Side effect

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A thoracic drain with a balloon is placed in the thoracic cavity during surgery. We evaluate whether chest pain changes by inflating the tip balloon the day after surgery.
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
1 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo pulmonary partial resection and aged 70 years or younger.
Key exclusion criteria Patients who undergo lobectomy or are over 70 years.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Sumitomo
Organization Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name Department of Thoracic Surgery
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL 06-6312-1221
Email rt-sumitomo@kitano-hp.or.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Sumitomo
Organization Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name Department of Thoracic Surgery
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL 06-6312-1221
Homepage URL
Email rt-sumitomo@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department

Funding Source
Organization Tazuke Kofukai Medical Research Institute, Kitano Hospital
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 kitano hospital
Address 2-4-20 Ohgimachi, Kita-ku
Tel 0663121221
Email rt-sumitomo@kitnao-hp.or.jp

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
2018 Year 01 Month 01 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 10
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
2017 Year 09 Month 21 Day
Date of IRB
2017 Year 12 Month 28 Day
Anticipated trial start date
2017 Year 12 Month 28 Day
Last follow-up date
2019 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033170

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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