| CTRI Number |
CTRI/2026/03/106742 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. 01-Version-04 dated 26 February 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Ranjan Mishra |
| Designation |
Principal Investigator & Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
H.O.D. Office (EM-2), Department of Emergency Medicine, Ground Floor, All India Institute of Medical Sciences, Ansari Nagar, New
Delhi
South
DELHI
110029
India |
| Phone |
918826118924 |
| Fax |
|
| Email |
ranjan.prakashmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Ranjan Mishra |
| Designation |
Principal Investigator & Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
H.O.D. Office (EM-2), Department of Emergency Medicine, Ground Floor, All India Institute of Medical Sciences, Ansari Nagar, New
Delhi
South
DELHI
110029
India |
| Phone |
918826118924 |
| Fax |
|
| Email |
ranjan.prakashmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayant Sitaram Karve |
| Designation |
Director and CEO |
| Affiliation |
RCupe Lifesciences Private Limited |
| Address |
Unit NO 1301, Ardent Office One Hoodi circle, Mahadevapura
Bangalore
KARNATAKA
560048
India |
| Phone |
918317438104 |
| Fax |
|
| Email |
jayant.karve@rcupe.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar, New
Delhi, Delhi-110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash Ranjan Mishra |
All India Institute of Medical Sciences, New Delhi |
Department of Emergency Medicine, Ground Floor, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI |
918826118924
ranjan.prakashmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Ozyn-D™, is a novel
Intraosseous (IO) |
The Ozyn-D™, intraosseous
device is primarily used during
medical emergencies as an
alternative to unsuccessful or
difficult intravenous access for
allowing access to circulation
to infuse fluids and
medications. The device will
be inserted at time 0 and
removed at 24 hours
post-insertion or until
intravenous access is
available, and whichever is
earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
The observation will be made right after insertion, at 30 min, 1 hour, 2 hour and 4 hours post insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of Ozyn-D™ as determined by
problem free infusion of
at least 50 mL of fluids through the IO route
without any adverse
event |
The observations will be made right after insertion, at
30 min, 1 hour, 2 hours and 4 hours post insertion |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The above-mentioned studies had certain limitations. The IO device was evaluated in adult human cadavers. While there are significant learnings from the above studies, these results cannot be extrapolated to the patients, clinically. Owing to the human cadaver, the occurrence of other live patient-related complications such as hematoma, infection, fat embolism could not be assessed. However, such complications have been reported to be rare with IO insertion. In the feasibility study discussed above, all insertions were done by a single operator. The device needs to be tested in patients to study the safety and effectiveness in performing its intended action. This forms the basis of the present study to evaluate the safety and efficacy of this device in patients where it is indicated for clinical use. |