臨床研究等提出・公開システム

Date of registration	Sept. 10, 2024
Last modified on	July. 23, 2026
Trial ID	jRCT2032240323

Scientific Title	Safety and performance confirmation study with dMD-003 - Study to evaluate the safety and performance of dMD-003 in patients scheduled to undergo planned two-stage hepatectomy -
Public Title	Safety and performance 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	+81-332256303
	E-mail	webmaster@mochida.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 01, 2024
Actual date of first enrollment		Nov. 19, 2024
Target sample size		15
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 with bilobar multiple liver metastasis from colon or rectal cancer who are eligible for a hepatectomy only if a planned two-stage hepatectomy is used. (2) Patients scheduled to undergo a second-stage hepatectomy at 2 to 12 weeks after the date of the initial hepatectomy. Other criteria.
	Exclusion Criteria	(1) Patients scheduled to undergo open resection along with the initial hepatectomy in the case of a concurrent primary colon or rectal tumor. (2) Patients with a history of open surgery for a primary colon or rectal tumor. (3) Patients who have previously undergone open surgery of the liver, bile duct, or upper abdomen. Other criteria.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Metastatic liver cancer
Intervention(s)		The study device (dMD-003) is applied, in principle, just under the wound (around the cut surface of the liver) immediately before wound closure in the initial surgery of a planned two-stage hepatectomy.
Primary Outcome(s)		(1) Zuhlke classification (2) TORAD score

Primary Sponsor	Mochida Pharmaceutical Co., Ltd.

Name of Certified Review Board	Cancer Institute Hospital of JFCR IRB
Address	3-8-1, Arirake, Koto-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	Toranomon Hospital and Toranomon Hospital Kajigaya IRB
Address	2-2-2, Toranomon, Minato-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	Kyorin University Hospital IRB
Address	6-20-2, Shinkawa, Mitaka-city, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	National Defense Medical College Hospital IRB
Address	3-2, Namiki, Tokorozawa-city, Saitama, Tokyo
Approval Status	Approval

Name of Certified Review Board	Dokkyo Medical University Hospital IRB
Address	880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Tokyo
Approval Status	Approval

Name of Certified Review Board	Juntendo University Hospital IRB
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	The University of Tokyo Hospital IRB
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	Saitama Medical Center IRB
Address	1981, Kamoda, Kawagoe-city, Saitama, Tokyo
Approval Status	Approval

Name of Certified Review Board	Tokyo Metropolitan Bokutoh Hospital IRB
Address	4-23-15, Kotobashi, Sumida-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	Ibaraki Prefectural Central Hospital IRB
Address	6528, Koibuchi Kasama-city, Ibaraki, Tokyo
Approval Status	Approval

Name of Certified Review Board	General Incorporated Association of Ethic Committee for Clinical Trials IRB
Address	2-12-13, Shinjyuku Shinjyuku-ku, Tokyo, Tokyo
Approval Status	Approval

Name of Certified Review Board	Komaki City Hospital IRB
Address	1-20, Jyobushi Komaki-city, Aichi, Tokyo
Approval Status	Approval

Name of Certified Review Board	Showa University Fujigaoka Hospital IRB
Address	1-30, Fujigaoka Aoba-ku Yokohama-city, Kanagawa, Tokyo
Approval Status	Approval

Name of Certified Review Board	Aso Iizuka Hospital IRB
Address	3-83, Yoshio-machi Iizuka-city, Fukuoka, Tokyo
Approval Status	Approval

Name of Certified Review Board	Medical Corporation Cattleyakai Mano Medical Clinic IRB
Address	1-8-1, Ebisu Shibuya-ku, Tokyo, Tokyo
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 23, 2026	(this page)	Changes
3	June. 02, 2026	Detail	Changes
2	Jan. 20, 2025	Detail	Changes
1	Sept. 10, 2024	Detail

List of change history