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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034734
Receipt No. R000039599
Official scientific title of the study Safety study of GM142 in patients scheduled to undergo surgery for benign gynecologic disease -Multicenter, open study-
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/15

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Basic information
Official scientific title of the study Safety study of GM142 in patients scheduled to undergo surgery for benign gynecologic disease -Multicenter, open study-
Title of the study (Brief title) A clinical trial of GM142 in patients undergoing surgery in the area of obstetrics and gynecology
Region
Japan

Condition
Condition Patients scheduled to undergo surgery for benign gynecologic disease
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety and operability of GM142 applied in patients scheduled to undergo surgery for benign gynecologic disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of adverse events within 12 weeks after surgery
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
Interventions/Control_1 GM142(Adhesion Barrier)
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

Not applicable
Gender Female
Key inclusion criteria 1. Female patients aged 20 years or older at the time of obtaining an informed consent
2. Patients who are scheduled to undergo laparoscopic surgery, laparoscopic-assisted surgery, or laparotomy for benign gynecologic disease
3. Patients who are fully informed about this study prior to the participation, understand the content, and give a written informed consent of their own free will
Key exclusion criteria (Preoperative criteria)
1. Patients who have a history of surgery in peritoneal cavity, except operation for appendicitis
2. Patients who had or have active pelvic inflammatory disease or peritonitis
3. Patients who are subject to emergency operation
4. Patients who have gelatin hypersensitivity
5. Patients who have a history of severe drug allergy
6. Patients who are severe diabetes or anomaly of saccharometabolism
7. Patients who are suspected of endometriosis of r-ASRM stage III (Moderate) or greater
8. Patients who require chronic treatment with corticosteroids
9. Patients who are scheduled to undergo radiotherapy or chemoradiotherapy during preoperative and postoperative periods
10. Patients who are scheduled to undergo chemotherapy within 2 weeks after surgery
11. Patients who are administered unapproved medications or medical devices within 12 weeks prior to obtaining the informed consent
12. Patients who are pregnant or lactating, or want to become pregnant during the clinical trial
13. Patients who are undergoing dialysis due to hepatic cirrhosis, active hepatitis, or chronic renal failure
14. Patients who are positive for any infection inappropriate for inclusion in the study based on the judgment of the principal investigator or sub-investigators
15. Patients who have psychiatric disease or symptom for which the enrollment in the study is judged unsuitable
16. Any other patients regarded unsuitable by the principal investigator or sub-investigators

(Preoperative criteria: In case of laparoscopic myomectomy)
17. Patients whose largest uterine fibroid has been found to be 10 cm or longer in length in preoperative MRI
18. Patients who have been found to have 10 or more uterine fibroids of 1 cm or larger in diameter in preoperative MRI

(Perioperative / Discontinuance criteria)
19. Patients who have been found to have endometriosis of r-ASRM score 16 points or over
20. Patients who have not applied GM142
Target sample size 30

Research contact person
Name of lead principal investigator Iwaho Kikuchi
Organization Juntendo University Urayasu Hospital
Division name Obstetrics and Gynecology
Address 2-1-1 Tomioka, Urayasu, Chiba
TEL 047-353-3111
Email kikuchiban@hotmail.com

Public contact
Name of contact person Muneaki Ezu
Organization GUNZE LIMITED
Division name Medical Division
Address 2-10-4 Nihonbashi,Chuo-ku,Tokyo
TEL 03-3276-8685
Homepage URL
Email GM142-all@gunze.co.jp

Sponsor
Institute GUNZE LIMITED
Institute
Department

Funding Source
Organization GUNZE LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 03 Day
Anticipated trial start date
2018 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039599

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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