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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019649
Receipt No. 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

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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
Obsterics 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
Email 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
Email tsuchiya@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022582

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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