UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031085 |
|---|---|
| Receipt number | 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 | 2022/08/09 08:13:03 |
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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
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
dhokka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.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 |
