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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041338
Receipt No. R000047093
Scientific Title Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Date of disclosure of the study information 2020/08/06
Last modified on 2020/08/06

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Basic information
Public title Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Acronym Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Scientific Title Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Scientific Title:Acronym Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Region
Japan

Condition
Condition Endometrial polyp
Retained products of conception (RPOC)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of hysteroscopic endometrial polypectomy using hysteroscopic morcellator system without anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of surgery
Key secondary outcomes 1. Operating time
2. Running time of morcellator
3. Fluid deficit
4. Insertion time during surgery
5. Adverse event
6. Pain, expectation, and satisfaction evaluated by patient
7. Recurrence of symptoms
8. Pregnancy rate, time to get pregnant

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 Maneuver
Interventions/Control_1 Hysteroscopic surgery using TruClear 5c system without anesthesia
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
70 years-old >
Gender Female
Key inclusion criteria 1. Patients who have required hysteroscopic 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 uterus bipartitus
2. Patients with intrauterine adhesion
3. Patients with endometrial carcinoma or suspected endometrial carcinoma
4. Patients who have experienced vasovagal syncope due to intrauterine procedure
5. Patients with endometrial polyp larger than 3 cm in diameter
6. Patients who are judged ineligible by the principal investigator or sub-investigators
Target sample size 75

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 5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
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 5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
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 Research Ethics Committee of the Faculty of Medicine of Teikyo University
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel 03-3964-7256 ext. 42203
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
2020 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 28 Day
Anticipated trial start date
2020 Year 08 Month 06 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 06 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047093

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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