UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026168 |
|---|---|
| Receipt number | R000029965 |
| Scientific Title | A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery. |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2019/10/02 11:45:47 |
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Basic information
Public title
A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Acronym
A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Scientific Title
A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Scientific Title:Acronym
A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and usefulness of the miniature wide-field camera system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
All adverse events during perioperative time.
Key secondary outcomes
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 |
Interventions/Control_1
The participation start date is the time of consent to this research, observation start time is the start of observation, and observation end time is the time of the end of surgery. In the case of
Pre-observation period: Up to one week from acquisition of consent to laparoscopic surgery
Research intervention period: the day when the laparoscopic assisted surgery was performed
Post-observation period: 28 days from the day of 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients whose age at agreement acquisition is from 20 years old to 80 years old.
2. Patients who are scheduled to undergo laparoscopic assisted colorectal resection at our hospital due to hospitalization (degree of progression of colorectal cancer does not matter).
3. Patient whose PS (ECOG) are either 0 or 1.
4. Patients whose main organ function are maintained.
Fulfill all of the following laboratory findings. (Use the latest inspection value within 30 days of registration)
1.T.bil less than 1.5 mg/dL
2.AST(GOT) less than 200 IU/L
3.ALT(GPT) less than 200 IU/L
4.Cr less than 1.2 mg/dL
5. Patients who obtain written consent regarding the participation of this study.
Key exclusion criteria
1. Patients with a history of abdominal surgery
2. Patients who are undergoing or plan to conduct anticoagulation therapy before and during surgery
3. Patients with a history of ischemic heart disease, cerebral infarction.
4. Patients judged by the research doctor to be inappropriate for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Graduate school of Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical & Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Mukai |
Organization
Graduate school of Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomed
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
TEL
082-257-5222
Homepage URL
mukais@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
SHARP corporation
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
Hiroshima University Hospital Clinical Research Ethics Committee
Address
1-2-3 Kasumi Minamiku Hiroshima
Tel
082-257-5947
iryo-seisaku@office.hiroshima-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
| 2017 | Year | 02 | Month | 21 | 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
| 2017 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 07 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029965
