UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014398 |
|---|---|
| Receipt number | R000016549 |
| Scientific Title | A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2017/03/11 22:49:03 |
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Basic information
Public title
A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Acronym
A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Scientific Title
A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Scientific Title:Acronym
A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the performance of a surgical stapling device, Endo GIA Reinforced Reload with Tri-Staple Technology, used in gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative duodenal stump leakage
Key secondary outcomes
Staple line hemostasis, any staple malformation, incidence of serosal injury, any additional suturing, amount of blood loss, duration of surgery, incidence of intraoperative and postoperative adverse events, duration of drain placement, duration of hospital stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 gastric cancer planned to undergo open or laparoscopic (distal or total) gastrectomy with Roux-en-Y reconstruction using a surgical stapling device
2)Patients aged 20 years or older
3)Patients with no history of upper abdominal surgery (with the exception of laparoscopic cholecystectomy)
4)Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
5)Patients with adequate functions of major organs
6)Patients who have provided written informed consent in person for participation in the study
Key exclusion criteria
1)Women who are pregnant or possibly pregnant, or breastfeeding
2)Patients receiving continuous systemic (oral or intravenous) steroid therapy
3)Patients with concurrent diabetes mellitus with poor control (HbA1c > 8.0%)
4)Patients with a history of allergy to nickel or chrome (a contraindication in IFU)
5)Patients with concurrent mental disorder or psychiatric symptoms judged to preclude participation in this study
6)Other patients judged by the investigator to be inappropriate as a subject of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Misawa |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Prefecture, 464- 8681
TEL
052-762-6111
misawakzn@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Misawa |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Prefecture, 464- 8681
TEL
052-762-6111
Homepage URL
misawakzn@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital, Department of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛知県がんセンター中央病院（愛知県）
神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, multi-center, single-arm, observational registry study
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016549
| 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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