UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000768 |
|---|---|
| Receipt number | R000000924 |
| Scientific Title | Clinical study on tissue adhesion preventive devices Trehalose based novel devices for postoperative tissue adhesions |
| Date of disclosure of the study information | 2007/07/16 |
| Last modified on | 2007/10/26 13:04:02 |
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Basic information
Public title
Clinical study on tissue adhesion preventive devices Trehalose based novel devices for postoperative tissue adhesions
Acronym
Clinical study on tissue adhesion preventive devices
Scientific Title
Clinical study on tissue adhesion preventive devices Trehalose based novel devices for postoperative tissue adhesions
Scientific Title:Acronym
Clinical study on tissue adhesion preventive devices
Region
| Japan |
Condition
Condition
Uterine leiomyoma, ovarian tumor, tubal adhesion, caesarotomy
Classification by specialty
| Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm clinical safety and efficacy of trehalose-based tissue adhesion preventive devices
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confirmation of safety and efficacy of trehalose-based tissue adhesion preventive devices
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 | Maneuver |
Interventions/Control_1
Trehalose-based tissue adhesion preventive device is sprayed over the whole operative field or abdominal cavity during laparoscopical or open abdominal surgery due to uterine leiomyoma, ovarian tumor or tubal adhesion, or during caesarotomy.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1 Patients who use Seprafilms during laparoscopical or open abdominal surgery due to uterine leiomyoma, ovarian tumor or tubal adhesion, or during caesarotomy.
2 Patients who can observe the protocol and are willing to and able to submit written informed consent.
3 Patients who have signed the written informed consent form approved by Institutional Review Board before subject screening.
Key exclusion criteria
1 Pregnant women, except for cesarean section patients
2 Patients who have received intravenous drip injections and, or perfusates containing dextran, heparin, corticosteroids or nonsteroidal antiinflammatory drugs.
3 Patients who chronically need to receive corticosteroids, or patients who are administered corticosteroids and, or nonsteroidal antiinflammatory drugs within 24 hours prior to surgeries.
4 Patients who have been treated with Interseeds or PRECLUDE surgical membranes or have received other antiadhesion treatments.
5 Patients in the physical conditions that can affect evaluation of safety and efficacy of the present device or Seprafilm.
6 Patients with histories of severe drug allergies.
7 Patients who have received other research products that might affect evaluations of safety and efficacy of the present device during the trial period.
8 Patients with active pelvic inflammatory diseases or peritonitis.
9 Patients who have had open abdominal operations.
10 Patients whose SGOT, SGPT or bilirubin level is more than 20 percent higher than each upper limit.
11 Patients whose BUN and creatinine level are more than 30 percent higher than each upper limit.
12 Patients with severe diabetes mellitus with over 8 percent of HbA1c.
13 Patients who are judged to be inappropriate for the study by doctors in their charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Taketani |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411(33400)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Fujiwara |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411(30534)
Homepage URL
fujiwart@air.linkclub.or.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
Institute
Department
Personal name
Funding Source
Organization
NEXT21 K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2007 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 13 | Day |
Last modified on
| 2007 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000924
