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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000039
Receipt No. 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

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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
Obsterics 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
Email

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/
Email jivrosgoffice@ml.res.ncc.go.jp

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000079

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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