臨床研究等提出・公開システム

Date of registration	Sept. 11, 2024
Last modified on	Feb. 04, 2025
Trial ID	jRCT2022240022

Scientific Title	Exploratory Trial of NP039 for Thoracic Aortic Replacement
Public Title	Exploratory Trial of NP039 for Thoracic Aortic Replacement

Contact for Scientific Queries	Name	Nishibata Nozomi
	Affiliation	NIPRO CORPORATION
	Address	3023, Nojicho, Kusatsu, Shiga
	Telephone	+81-77-564-9467
	E-mail	nishibata-nozomi@nipro.co.jp
Contact for Public Queries	Name	Nishibata Nozomi
	Affiliation	NIPRO CORPORATION
	Address	3023, Nojicho, Kusatsu, Shiga
	Telephone	+81-77-564-9467
	E-mail	nishibata-nozomi@nipro.co.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Dec. 01, 2024
Target sample size		40
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	-Written informed consent from patients or legal representative if patients lack of ability to consent. -Over 18 years of age at the time of acquiring consent. , etc.
	Exclusion Criteria	1. emergency surgery patients 2. patients undergoing revision surgery on the same incision site 3. poorly controlled diabetic patients 4. immunocompromised patients 5. patients with severe drug allergy ,etc.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Patients with vascular anastomoses that may not achieve hemostasis by ligation or normal surgical pr
Intervention(s)		The anastomosis will be reinforced with the investigational device NP039 or the control device by random assignment and the examinations and observations specified in the protocol will be performed.
Primary Outcome(s)		Reinforcement success rate per case

Primary Sponsor	NIPRO CORPORATION

Name of Certified Review Board	Tohoku University Hospital Institutional Review Board
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan, Miyagi
Telephone	+81-22-717-7000
E-Mail	chiken@chiken.hosp.tohoku.ac.jp
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 04, 2025	(this page)	Changes
1	Sept. 11, 2024	Detail

List of change history