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Recruitment status Completed
Unique ID issued by UMIN UMIN000008739
Receipt No. 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

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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
Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email Kazuhisa.Senshu@terumo-europe.com

Sponsor
Institute Terumo Europe N.V.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010262


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