UMIN-CTR Clinical Trial

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://center6.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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