Unique ID issued by UMIN | UMIN000041338 |
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Receipt number | 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 | 2023/08/09 13:54:51 |
Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia
Japan |
Endometrial polyp
Retained products of conception (RPOC)
Obstetrics and Gynecology |
Others
NO
The purpose of this study is to evaluate the efficacy and safety of hysteroscopic endometrial polypectomy using hysteroscopic morcellator system without anesthesia.
Safety,Efficacy
Success rate of surgery
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Hysteroscopic surgery using TruClear 5c system without anesthesia
20 | years-old | <= |
70 | years-old | > |
Female
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
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
75
1st name | Osamu |
Middle name | |
Last name | Nishii |
University Hospital, Mizonokuchi, Teikyo University School of Medicine
Obstetrics and Gynecology
2130002
5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
044-844-3333
nishii@med.teikyo-u.ac.jp
1st name | Akira |
Middle name | |
Last name | Tsuchiya |
University Hospital, Mizonokuchi, Teikyo University School of Medicine
Obstetrics and Gynecology
2130002
5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan
044-844-3333
tsuchiya@med.teikyo-u.ac.jp
Teikyo University
Teikyo University
Self funding
Research Ethics Committee of the Faculty of Medicine of Teikyo University
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
03-3964-7256 ext. 42203
turb-office@teikyo-u.ac.jp
NO
帝京大学医学部附属溝口病院(神奈川県)
2020 | Year | 08 | Month | 06 | Day |
Unpublished
Completed
2020 | Year | 07 | Month | 28 | Day |
2020 | Year | 07 | Month | 28 | Day |
2020 | Year | 08 | Month | 06 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 08 | Month | 06 | Day |
2023 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047093
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