UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008739 |
|---|---|
| Receipt number | R000010262 |
| Scientific Title | Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery |
| Date of disclosure of the study information | 2012/08/21 |
| Last modified on | 2015/08/24 08:15:42 |
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Basic information
Public title
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Acronym
ADBEE study
Scientific Title
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Scientific Title:Acronym
ADBEE study
Region
| Europe |
Condition
Condition
primary removal of myomas in women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and the manageability and usability of the ADBLOCK Adhesion Barrier System in laparoscopic surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group up to 28 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
implanation of ADBLOCK gel
Interventions/Control_2
surgery only
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
i)Female
ii)18-45 years
iii)Indication for laparoscopic myomectomy according to the medical standard
iv)Negative pregnancy test before study entry
v)Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse)
vi)In good health including an ASA (American Society of Anesthesiologists) score of 2 or less
vii)No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment
viii)Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma)
ix)Willing, able and likely to fully comply with study procedures and restrictions
x)Given written, personally signed and dated informed consent to participate in the study as approved by the Institutional Review Board/Ethics Committee of the respective Clinical Study Site.
Key exclusion criteria
Pre-Operative Exclusion Criteria:
i)Women who have completed their family planning
ii)Current pregnancy including ectopic pregnancy
iii)Breastfeeding
iv)6 weeks post-partum
v)Participation in another clinical study currently or within the last 30
days prior to enrolment
vi)SGOT, SGPT and/or bilirubin >20% above the upper range of normal and considered clinically significant
vii)BUN and creatinine >30% above the upper range of normal and
considered clinically significant
viii)Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation
ix)Previous radiation therapy
x)Diabetes
xi)Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders
xii)Active pelvic or abdominal infection, or other infection with fever
xiii)Extensive keloid scarring
xiv)Known allergy to starch-based polymers
xv)Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients
xvi)Additional surgical procedure non-obstetrics and gynaecology (non-
OB/GYN) planned to be performed during the laparoscopic procedure
xvii)4 myoma larger than 2 cms on preoperative ultrasound
screen
xviii)Largest myoma <2 cms or >8 cms diameter on pre-operative screen
xix)GNRH agonist/antagonist treatment (except oral contraceptive;
combined oestrogen/progesterone) in the 4 weeks prior to study
xx)Prior surgery for myoma
xxi)Prevoius bowl surgery, excluding appendectomy
xxii)Prior intra-abdominopelvic adhesive complications
Intraoperative Exclusion Criteria
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof Rudy-Leon De Wilde |
Organization
Pius Hospital
Division name
Department of Obstetrics, Gynecology and Gynecological Oncology
Zip code
Address
Georgstr 12, Oldenburg, 26121, Germany
TEL
+49(441)2291501
Rudy-leon.dewilde@pius-hospital.de
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa SENSHU |
Organization
Terumo Europe N.V.
Division name
European Medical and clinical div
Zip code
Address
interleuvenlaan 40, B-3001, Leuven, Belgium
TEL
+3216381524
Homepage URL
Kazuhisa.Senshu@terumo-europe.com
Sponsor or person
Institute
Terumo Europe N.V.
Institute
Department
Personal name
Funding Source
Organization
Terumo Europe N.V.
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
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
| 2012 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 21 | Day |
Last modified on
| 2015 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010262
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
