臨床研究等提出・公開システム

Date of registration	Oct. 01, 2021
Last modified on	Oct. 20, 2022
Trial ID	jRCT2022210040

Scientific Title	Pilot study of dMD-002 - A study on the efficacy and safety of dMD-002 in patients with neurovascular bundles injury during radical prostatectomy -
Public Title	Pilot study of dMD-002 in patients with neurovascular bundles injury during radical prostatectomy -

Contact for Scientific Queries	Name	Nakamura Masaki
	Affiliation	Mochida Pharmaceutical Co., Ltd.
	Address	7, Yotsuya 1-chome, Shinjuku-ku, Tokyo 160-8515, Japan
	Telephone	+81-3-3225-6306
	E-mail	dmd001.mdbd@mochida.co.jp
Contact for Public Queries	Name	relations Public
	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	Not Recruiting

Anticipated date of first enrollment		Oct. 01, 2021
Target sample size		12
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients diagnosed with prostate cancer (2) Patients scheduled for radical prostatectomy (non-nerve sparing or unilateral nerve-sparing) by robot-assisted laparoscopic surgery etc.
	Exclusion Criteria	(1) Patients required radiation therapy, endocrine therapy or antineoplastic therapy before or after radical prostatectomy (2) Patients taking PDE5 inhibitors (3) Patients using negative pressure erection apparatus
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Prostate cancer
Intervention(s)		The cut dMD-002 is implanted to cover the nerve injury, tear, or defect, and is fixed by suturing to the surrounding tissue in two or more places.
Primary Outcome(s)		Efficacy Change in EHS Change in IIEF EF Change in EPIC sxual function(Q17 to 23) Safety Advere event defect

Primary Sponsor	Mochida Pharmaceutical Co., Ltd.

Source of Monetary Support	Sponsored research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Akita University Hospital Institutional Review Board
Address	44-2 Hasunuma, Hiroomote, Akita-shi, Akita
Telephone	+81-18-884-6029
E-Mail	soken@hos.akita-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 26, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Oct. 20, 2022	(this page)	Changes
4	Dec. 20, 2021	Detail	Changes
3	Nov. 24, 2021	Detail	Changes
2	Oct. 08, 2021	Detail	Changes
1	Oct. 01, 2021	Detail

List of change history