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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000000768
Receipt No. 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

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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
Obsterics 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)
Email

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
Email fujiwart@air.linkclub.or.jp

Sponsor
Institute The University of Tokyo Hospital
Department of Obstetrics & Gynecology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000924

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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