UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019649 |
|---|---|
| Receipt number | R000022582 |
| Scientific Title | Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study) |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2019/05/10 18:43:12 |
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Basic information
Public title
Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study)
Acronym
Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system
Scientific Title
Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study)
Scientific Title:Acronym
Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system
Region
| Japan |
Condition
Condition
Submucous myoma
Endometrial polyp
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the efficacy and safety of TRUCLEAR system vs. conventional resectoscopy in patients requiring hysteroscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Operating time
Key secondary outcomes
1. Removal success
2. Fluid deficit
3. Convenience with technique
4. Insertion time during surgery
5. Visibility of Operation Field
6. Recurrence of chief complaint
7. Adverse event
8. Pain, expectation, and satisfaction evaluated by patient
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hysteroscopic surgery performed with TRUCLEAR system
Interventions/Control_2
Hysteroscopic surgery performed with conventional Resectoscopy
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. Patients who have required hysteroscopic myomectomy or polypectomy
2. Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement in a format approved by the institution site
Key exclusion criteria
1. Patients with submucous myoma larger than 2 cm in diameter
2. Patients with FIGO type 2 submucous myoma
3. Patients who have received hysteroscopic myomectomy or polypectomy before
4. Patients with uterus bipartitus
5. Patients with intrauterine adhesion
6. Patients with endometrial carcinoma or suspected endometrial carcinoma
7. Patients who are judged ineligible by the principal investigator or sub-investigators
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishii |
Organization
University Hospital, Mizonokuchi,
Teikyo University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
2130002
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-844-3333
nishii@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tsuchiya |
Organization
University Hospital, Mizonokuchi, Teikyo University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
2130002
Address
3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-844-3333
Homepage URL
tsuchiya@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Teikyo University
Address
2-11-1 Kaga Itabashi-ku Tokyo Japan
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
帝京大学医学部附属溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30254929
Number of participants that the trial has enrolled
70
Results
The polyps were completely removed, and no adverse events were observed in all 67 patients. The average operating time (8.3 min vs. 12.0 min, P = 0.014), insertion time (5.0 min vs. 9.0 min, P < 0.001), and number of insertions (1.0 vs. 8.2, P < 0.001) were significantly lower in the morcellation arm than in the electrosurgical resection arm.
Results date posted
| 2019 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 02 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Patients undergoing hysteroscopic resection of endometrial polyps were randomly allocated to undergo hysteroscopic morcellation or electrosurgical resection.
Adverse events
Outcome measures
The primary outcome was the operating time. Secondary outcomes were the removal success, fluid deficit, convenience with the technique, insertion time, number of insertions during the operation, visibility of the operative field, recurrence of the patient's chief complaint, and adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022582
