UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000039 |
|---|---|
| Receipt number | R000000079 |
| Scientific Title | A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302) |
| Date of disclosure of the study information | 2005/08/05 |
| Last modified on | 2012/09/21 13:18:41 |
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Basic information
Public title
A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302)
Acronym
Uterine artery embolization using gelatine sponge for uterine leiomyoma (JIVROSG-0302)
Scientific Title
A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302)
Scientific Title:Acronym
Uterine artery embolization using gelatine sponge for uterine leiomyoma (JIVROSG-0302)
Region
| Japan |
Condition
Condition
Symptomatic uterine leimoyoma
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of uterine artery embolization using gelatine sponge in patients with symptomatic uterine leiomyoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Improvement of symptoms, decrease of the volume of leiomyoma, changes in ovarian function, length of hospital stay.
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
| Maneuver |
Interventions/Control_1
Bilateral uterine arteries are embolized with gelatine sponge particles using microcatheter system inserted by Seldinger's technique. The embolization is terminated when the stasis of blood flow in the ascending branch of uterine arteries is observed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Symptomatic uterine leiomyomas confirmed by imaging studies with MRI or US.
2) Uncontrolled symptoms with medical therapies.
3) Premenopausal.
4) Adecuate cardiac, hepatic, renal, respiratory, and bone marrow functions.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
6) Written informed consent.
Key exclusion criteria
1) Pregnant, nursing, or desiring future pregnancy.
2) Active pelvic inflammatory disease.
3) Pelvic malignancy.
4) Previous hormonal therapy within 12 weeks.
5) Contraindication to MRI.
6) Contraindication to iodized contrast material.
7) Uncontrolled cardiac, respiratory, gastrointestinal, or nervous disorders. Uncontrolled diabetes, hypertension, or infection.
8) Adenomyosis confirmed with MRI.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyuki Sone |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
Address
19-1, Uchimaru, Morioka 020-8505, Japan
TEL
019-651-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
JIVROSG, Coordinating Office
Division name
Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/
jivrosgoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
| 2005 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
http://jivrosg.umin.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/20884240
Number of participants that the trial has enrolled
Results
-Technical success was achieved in all patients.
-Median follow-up period was 33 months.
-Minor AEs occurred in 10 pts (33%) and major AEs in two (6%). The most common AE was transient amenorrhea.
-Median hospital stay was five days.
-The rates of symptom improvement at 12 months were: menorrhagia, 90%; pelvic pain,77%;bulk-related symptoms, 96%.
-The mean reduction rate in leiomyoma volume on MRI at 12 month was 61%.
: Presented at SIR 2008, Washington D.C.
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
| 2004 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 05 | Day |
Last modified on
| 2012 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000079
