臨床研究等提出・公開システム

Date of registration	Nov. 11, 2023
Last modified on	July. 23, 2026
Trial ID	jRCT2072230089

Scientific Title	Confirmatory trial with dMD-003 - Non-inferiority confirmatory study of dMD-003 to Seprafilm in patients with primary rectal cancer scheduled to undergo temporary loop ileostomy -
Public Title	Confirmatory trial 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 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		Nov. 01, 2023
Actual date of first enrollment		Jan. 12, 2024
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients with initial and primary rectal cancer. (2) Patients with cStage 0 to cStage III cancer. (3) Patients who are scheduled to undergo laparoscopic or robot-assisted rectal resection in which a temporary ileostomy is scheduled to be performed. Other criteria.
	Exclusion Criteria	(1) Patients who have previously undergone surgery in the abdominal cavity (excluding appendicitis surgery). (2) Patients with cStage IV cancer. (3) Patients who are scheduled to have samples removed from a site other than the midline incision. Other criteria.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Rectal cancer
Intervention(s)		The study device (dMD-003 or Seprafilm) is applied, in principle, under the midline incision immediately before wound closure in a temporary ileostomy.
Primary Outcome(s)		Presence or absence of adhesion.

Primary Sponsor	Mochida Pharmaceutical Co., Ltd.

Name of Certified Review Board	Fukuoka University Hospital IRB
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Central IRB
Address	Mita Kokusai Bldg.21F, 1-4-28, Mita, Minato-ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Kochi Health Sciences Center IRB
Address	2125-1, Ike, Kochi-city, Kochi, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Gunma Prefectural Cancer Center IRB
Address	617-1, Takabayashi Nishi-machi, Ota-city, Gunma, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic IRB
Address	1-13-8, Bessho, Minami-ku, Yokohama-city Kanagawa, Kanagawa, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Saitama Medical University International Medical Center, Medical device clinical trial IRB
Address	1397-1, Yamane, Hidaka-city, Saitama, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Toranomon Hospital and Toranomon Hospital Kajigaya IRB
Address	2-2-2, Toranomon, Minato-ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Hyogo College of Medicine Hospital IRB
Address	1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Shizuoka General Hospital IRB
Address	4-27-1, Kitaando, Aoi-ku, Shizuoka-city, Shizuoka, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Juntendo Hospital IRB
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Japanese Red Cross Kumamoto Hospital IRB
Address	2-1-1, Nagamine Minami, Higashi-ku, Kumamoto-city, Kumamoto, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Kyorin University Hospital IRB
Address	6-20-2, Shinkawa, Mitaka-city, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Yokosuka Kyosai Hospital IRB
Address	1-16, Yonegahamadori Yokosuka-city, Kanagawa, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Osaka General Medical Center IRB
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka-city, Osaka, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Hiroshima City North Medical Center Asa Citizens Hospital IRB
Address	1-2-1, Kameyamaminami, Asakita-ku, Hiroshima-city, Hiroshima, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Yokohama City University Medical Center IRB
Address	4-57, Urafune-cho, Minami-ku, Yokohama-city, Kanagawa, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Tokyo Medical and Dental University Hospital IRB
Address	1-5-45, Yushima, Bunkyo-Ku, Tokyo, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

Name of Certified Review Board	Sapporo Medical University Hospital IRB
Address	16-291, West, South 1-jo, Chuo-ku, Sapporo, Hokkaido, Fukuoka
Approval Status	Approval
Date of approval	Nov. 01, 2023

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	Oct. 14, 2025	Detail	Changes
2	June. 27, 2024	Detail	Changes
1	Nov. 11, 2023	Detail

List of change history