臨床研究等提出・公開システム

Date of registration	Nov. 07, 2023
Last modified on	Oct. 14, 2025
Trial ID	jRCT2072230083

Scientific Title	Safety confirmation study with dMD-003 - Study to evaluate the safety of dMD-003 in patients scheduled to undergo uterine myomectomy -
Public Title	Safety confirmation study with dMD-003

Contact for Scientific Queries	Name	Aihara Fumiaki
	Affiliation	Mochida Pharmaceutical Co., Ltd.
	Address	7, Yotsuya 1-chome, Shinjuku-ku, Tokyo
	Telephone	+81-3-3225-6306
	E-mail	dmd003.mdbd@mochida.co.jp
Contact for Public Queries	Name	Public relations
	Affiliation	Mochida Pharmaceutical Co., Ltd.
	Address	7, Yotsuya 1-chome, Shinjuku-ku, Tokyo
	Telephone	+81-3-3225-6303
	E-mail	webmaster@mochida.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 01, 2023
Actual date of first enrollment		April. 12, 2024
Target sample size		30
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	(1) Patients scheduled to undergo laparoscopic, laparoscopy-assisted, or open uterine myomectomy. Other criteria.
	Exclusion Criteria	(1) Patients who have undergone surgery in the abdominal or pelvic cavity (excluding surgery for appendicitis). (2) Patients with concurrent active pelvic inflammatory disease or peritonitis. (3) Patients suspected of having moderate (stage III) or severe endometriosis according to the r-ASRM classification. Other criteria.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Uterine leiomyoma
Intervention(s)		The study device (dMD-003) is applied to the injury site of the uterus immediately before wound closure in uterine myomectomy.
Primary Outcome(s)		Incidence of adverse events up to 12 weeks after surgery.

Primary Sponsor	Mochida Pharmaceutical Co., Ltd.

Name of Certified Review Board	Northern Kyushu Saiseikai Hospitals combination IRB
Address	1-3-46 Tenjin, Chuo-ku, Fukuoka-shi, Fukuoka, Fukuoka
Approval Status	Approval
Date of approval	Oct. 04, 2023

Name of Certified Review Board	Japanese Red Cross Kumamoto Hospital IRB
Address	2-1-1, Nagamine Minami, Higashi-ku, Kumamoto-shi, Kumamoto, Fukuoka
Approval Status	Approval
Date of approval	Oct. 04, 2023

Name of Certified Review Board	Shoda Hospital IRB
Address	1-16-32 Annaka, Annaka-city, Gunma, Fukuoka
Approval Status	Approval
Date of approval	Oct. 04, 2023

Name of Certified Review Board	St. Luke's International Hospital IRB
Address	9-1 Akashi-cho, Chuo-ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Oct. 04, 2023

Name of Certified Review Board	Tokyo Medical University Hospital IRB
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Oct. 04, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Oct. 14, 2025	(this page)	Changes
3	Jan. 14, 2025	Detail	Changes
2	June. 27, 2024	Detail	Changes
1	Nov. 07, 2023	Detail

List of change history