Exploratory Trial of NP039 for Thoracic Aortic Replacement

JRCT ID: jRCT2022240022

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with vascular anastomoses that may not achieve hemostasis by ligation or normal surgical pr
• Date of first enrollment: 01/12/2024
• Target sample size: 40
• Countries of recruitment: none,Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Reinforcement success rate per case

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nishibata Nozomi