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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020317
Receipt No. R000023460
Scientific Title Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Date of disclosure of the study information 2015/12/23
Last modified on 2018/11/20

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Basic information
Public title Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Acronym Assessments of usefulness and safety; the inflated bag laparoscopic surgery.
Scientific Title Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Scientific Title:Acronym Assessments of usefulness and safety; the inflated bag laparoscopic surgery.
Region
Japan

Condition
Condition gynecologic disease, benign
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate usefulness and safety of in bag morcellation used inflated intraperitoneal isolation bag in the gynecologic laparoscopic surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes status of vital sign in the operation, included pressures of the intraperitoneum and the airway.
Key secondary outcomes surgical duration

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 using the intraperitoneal isolation bag inflated by CO2 pneumoperitoneum system
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
80 years-old >
Gender Female
Key inclusion criteria Patients which need the tumor morcellation in the peritoneal cavity
Key exclusion criteria patients which have not to use inflated isolation bag
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Ichikawa
Organization Japanese Red Cross, Shizuoka hospital
Division name obstetrics and gynecology
Zip code
Address 8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL 054-254-4311
Email ichikawa-obgyn@szrc.org

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Ichikawa
Organization Japanese Red Cross, Shizuoka hospital
Division name obstetrics and gynecology
Zip code
Address 8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL 054-254-4311
Homepage URL
Email ichikawa-obgyn@szrc.org

Sponsor
Institute Japanese Red Cross, Shizuoka hospital
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 静岡赤十字病院(静岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 23 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
Our experiment will be terminated on Dec 31st, 2018.  Because the bags had already been sold, which was allowed to inflate in the  patient's abdominal cavity. The importance to continue the experimental treatment using non-authorization bag and off-label use bag disappeared. 

 Furthermore, the authorized inflatable bags were not able to make stable conditions in the patients abdominal cavities. Because we could not get the credible data on each tests, we could not show the safety and the effectiveness that were the purpose of the examination.
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 Terminated
Date of protocol fixation
2014 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information We will terminated on December 31, 2018 from the viewpoint of compatibility to a new clinical trial law.

Management information
Registered date
2015 Year 12 Month 23 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023460

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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