臨床研究等提出・公開システム

Date of registration	Dec. 23, 2021
Last modified on	Oct. 07, 2023
Trial ID	jRCT2072210100

Scientific Title	An Open-label Study of SI-449 Resorbable Adhesion Barrier System in Patients Undergoing Laparoscopic Uterine Myomectomy.
Public Title	An Open-label Study of SI-449 in Patients Undergoing Laparoscopic Uterine Myomectomy.

Contact for Scientific Queries	Name	Sagawa Kenji
	Affiliation	SEIKAGAKU CORPORATION
	Address	6-1, Marunouchi 1, Chiyoda-ku, Tokyo 100-0005, Japan.
	Telephone	+81-3-5220-8593
	E-mail	reply@seikagaku.co.jp
Contact for Public Queries	Name	Ando Kumi
	Affiliation	SEIKAGAKU CORPORATION
	Address	6-1, Marunouchi 1, Chiyoda-ku, Tokyo 100-0005, Japan.
	Telephone	+81-3-5220-8593
	E-mail	reply@seikagaku.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 31, 2022
Actual date of first enrollment		Jan. 27, 2022
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects undergoing laparoscopic uterine myomectomy.
	Exclusion Criteria	1. Subjects with history of surgery in the abdominal or pelvic cavity. 2. Subjects with having active infection in the abdominal or pelvic cavity. 3. Subjects with history of hypersensitivity to the investigational device. 4. Subjects with a serious hepatic or a serious renal disorder. 5. Subjects who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent.
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Uterine myoma
Intervention(s)		SI-449 Resorbable Adhesion Barrier System will be applied to subjects undergoing laparoscopic uterine myomectomy.
Primary Outcome(s)		Operability, safety

Primary Sponsor	SEIKAGAKU CORPORATION

Secondary Sponsor

Name of Certified Review Board	Northern Kyushu Saiseikai Hospitals combination IRB
Address	1-3-46 Tenjin, Chuo-ku, Fukuoka-shi, Fukuoka, 810-0001, Japan, Fukuoka
Telephone	+81-92-771-8151
E-Mail	chiken@saiseikai-hp.chuo.fukuoka.jp
Approval Status	Approval
Date of approval	Dec. 15, 2021

Name of Certified Review Board	Atago dermatology clinic institutional review board
Address	1-1-35, Shibadaimon, Minato-ku, Tokyo, Fukuoka
Telephone	+81-42-648-5551
E-Mail	atagohihuka-irb@eps.co.jp
Approval Status	Approval
Date of approval	Dec. 15, 2021

Name of Certified Review Board	Tokyo Women's Medical University Institutional Review Board
Address	8-1,Kawada-cho,Shinjuku-ku,Tokyo,Japan, Fukuoka
Telephone	+81-3-3353-8111
E-Mail	chiken.bm@twmu.ac.jp
Approval Status	Approval
Date of approval	Dec. 15, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	Oct. 07, 2023	(this page)	Changes
7	April. 16, 2023	Detail	Changes
6	Aug. 10, 2022	Detail	Changes
5	July. 29, 2022	Detail	Changes
4	May. 25, 2022	Detail	Changes
3	Feb. 05, 2022	Detail	Changes
2	Jan. 08, 2022	Detail	Changes
1	Dec. 23, 2021	Detail

List of change history