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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031085
Receipt No. R000035498
Scientific Title Randomized controlled trial evaluating single port thoracic surgery with x-Gate for spontaneous pneumothorax.
Date of disclosure of the study information 2018/03/20
Last modified on 2019/05/09

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Basic information
Public title Randomized controlled trial evaluating single port thoracic surgery with x-Gate for spontaneous pneumothorax.
Acronym Randomized controlled trial evaluating single port thoracic surgery with x-Gate for spontaneous pneumothorax.
Scientific Title Randomized controlled trial evaluating single port thoracic surgery with x-Gate for spontaneous pneumothorax.
Scientific Title:Acronym Randomized controlled trial evaluating single port thoracic surgery with x-Gate for spontaneous pneumothorax.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of single port
thoracic surgery with x-GATE for spontaneous pneumothorax in young patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes degree of postoperative pain (POD 7, Visual Analogue Scale(VAS))
Key secondary outcomes pneumothorax recurrence, intraoperative blood loss, operation time, frequency of intraoperative and postoperative complications, duration of drainage, postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 single-port thoracoscopic surgery with x-GATE
Interventions/Control_2 conventional three-port thoracoscopic surgery
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
15 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who have spontaneous pneumothorax,
and the lesion (bulla or bleb) is located in the apex or peripheral side of lung.
(2) Patients who are over 15 years and under 35 of age at the time of consent.
(3) Patients who received informed consent to attend this study, and the agreements are provided in a document.
Key exclusion criteria (1) Patients with secondary pneumothorax.
(2) Patients with severe liver or renal diseases.
(3) Patients with severe allergy.
(4) Patients who are judged ineligible by the investigator and the attending surgeon
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Hokka
Organization Kobe University International Clinical Cancer Research Center
Division name Division of Thoracic Surgery
Zip code 650-0047
Address 1-5-1minatojimaminami-machi, Chuo-ku, Kobe, Japan
TEL 078-382-5750
Email dhokka@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Hokka
Organization Kobe University Graduate School of Medicine
Division name Division of Thoracic Surgery
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-ku
TEL 0783825750
Homepage URL http://www.med.kobe-u.ac.jp/gts/index.html
Email dhokka@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University 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 KOBE Univ. Hosp. Clinical and Translation Research center
Address 7-5-2, Kusunoki-cho, Chuo-ku
Tel 0783826669
Email chiken@med.kobe-u.ac.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 03 Month 20 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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 07 Month 24 Day
Last follow-up date
2022 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 31 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035498

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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