A study to evaluate the safety and effectiveness of a device that delivers medicines and fluids through the bone instead of a vein in patients who need emergency treatment.

Prospective, Open Label, Single Arm, Interventional, Single Centre, Pilot Study to Evaluate the Safety, and Effectiveness of Ozyn-DTM, a Novel Intraosseous device for delivery of Medications and fluids - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106742

Enrollment

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: Ozyn-D, a novel intraosseous device: The Ozyn-D, intraosseous device is primarily used during medical emergencies as an alternative to unsuccessful or difficult intravenous access for a

Eligibility

Inclusion criteria

Inclusion criteria: Following subjects will be included in the study: 1. Adult male or female subjects greater than or equal to 18 years of age. 2.Visiting emergency department and 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Safety of Ozyn-D will be assessed by: i. Frequency, incidence and severity of device,patient and procedure related complications and other adverse events. ii. Evidence of problem-free infusion of fluids without soft tissue swelling Adverse events will be assessed on a continuous basis from the procedure through the study completion.Timepoint: The observation will be made right after insertion, at 30 min, 1 hour, 2 hour and 4 hours post insertion.	—

Measure

Time frame

Safety of Ozyn-D will be assessed by: i. Frequency, incidence and severity of device,patient and procedure related complications and other adverse events. ii. Evidence of problem-free infusion of fluids without soft tissue swelling Adverse events will be assessed on a continuous basis from the procedure through the study completion.Timepoint: The observation will be made right after insertion, at 30 min, 1 hour, 2 hour and 4 hours post insertion.

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Secondary

Measure	Time frame
Effectiveness of Ozyn-D as determined by problem free infusion of at least 50 mL of fluids through the IO route without any adverse eventTimepoint: The observations will be made right after insertion, at 30 min, 1 hour, 2 hours and 4 hours post insertion	—

Countries

India

Contacts

Public ContactJayant Sitaram Karve

All India Institute of Medical Sciences, New Delhi

ranjan.prakashmishra@gmail.com918826118924

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026