Prospective, Open-label, Single Arm, Interventional, Multicentric, Pilot Study to Evaluate the Safety, and Effectiveness of Ozyn-Dâ?¢, a Novel Intraosseous device for Delivery of Medications and Fluids

RCupe Lifesciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

暂无简介。

•Following subjects will be included in the study: 1. Adult male or female subjects greater than or equal to 18 years of age. 2. Hospitalized in the ward requiring vascular access, in whom attempts to secure IV access have failed after performing 3 attempts.3. Must be able to comply with the study related procedures. 4. Subject or the legally accepted representative willing to provide written Informed Consent before any study-specific tests or procedures are performed.

•Following subjects will be excluded from the study:
•1. Patients below 18 years.
•2. Areas of cellulitis, burns, or infection at the target site of IO access.
•3. Pregnant or lactating women.
•4. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
•5. Known or suspected immuno-compromised subjects
•6. Known/suspected case of bleeding &/or coagulation disorders
•7. Known/suspected case of multiple myeloma, metastatic diseases.
•8. Known/suspected case of pathophysiological conditions at skin, bone, or tissue at or near target site
•9. Known/suspected patients with intracardiac shunts.
•10. Patients with known/suspected fracture or vascular injury distal or proximal to the target site.
•11. Any condition not found appropriate as per the Investigator discretion.

发起方

RCupe Lifesciences Private Limited