UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034734 |
|---|---|
| Receipt number | R000039599 |
| Scientific Title | 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 | 2023/02/06 16:45:39 |
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Basic information
Public title
Safety study of GM142 in patients scheduled to undergo surgery for benign gynecologic disease -Multicenter, open study-
Acronym
A clinical trial of GM142 in patients undergoing surgery in the area of obstetrics and gynecology
Scientific Title
Safety study of GM142 in patients scheduled to undergo surgery for benign gynecologic disease -Multicenter, open study-
Scientific Title:Acronym
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
| Obstetrics 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
| 1st name | Iwaho |
| Middle name | |
| Last name | Kikuchi |
Organization
Medical Park Yokohama
Division name
Gynecology
Zip code
231-0062
Address
1-1-8-4F, Sakuragi-cho, Naka-ku,Yokohama-shi, Kanagawa
TEL
045-232-4741
kikuchiban@hotmail.com
Public contact
Name of contact person
| 1st name | Muneaki |
| Middle name | |
| Last name | Ezu |
Organization
GUNZE LIMITED
Division name
Medical Division
Zip code
103-0027
Address
2-10-4 Nihonbashi,Chuo-ku,Tokyo
TEL
03-3276-8685
Homepage URL
GM142-all@gunze.co.jp
Sponsor or person
Institute
GUNZE LIMITED
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Juntendo University Urayasu Hospital Institutional Review Board
Address
2-1-1 Tomioka, Urayasu City, Chiba
Tel
042-353-3111
ju-gcp@juntendo-urayasu.jp
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 |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/jog.15527
Number of participants that the trial has enrolled
34
Results
https://doi.org/10.1111/jog.15527
Results date posted
| 2023 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://doi.org/10.1111/jog.15527
Participant flow
https://doi.org/10.1111/jog.15527
Adverse events
https://doi.org/10.1111/jog.15527
Outcome measures
https://doi.org/10.1111/jog.15527
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039599
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