UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029236 |
|---|---|
| Receipt number | 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 11:38:11 |
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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
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
rt-sumitomo@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
