| CTRI Number |
CTRI/2024/06/068328 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| 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 tolerability of nasal dressing (VELNEZ) after a nasal surgery. |
|
Scientific Title of Study
|
A post marketing clinical follow-up study (PMCF) to evaluate safety and tolerability of VELNEZ as a nasal pack after nasal surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/CIP-003-2024/CT/VN, Version 1.0, date 19-Feb-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Munjal |
| Designation |
Sr. Consultant, ENT Surgeon |
| Affiliation |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Department of ENT, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi
West
DELHI
110060
India |
| Phone |
9971149996 |
| Fax |
|
| Email |
may2manish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
VP and R and D Head |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
52-54,63 & 64, Roz Ka Meo Industrial Area Nuh, Distt. Mewat
56, Community Center, East of Kailash, New Delhi
Gurgaon
HARYANA
122103
India |
| Phone |
9315829298 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
General Manager Clinical Research Operations |
| Affiliation |
Datt Mediproducts Pvt Ltd. |
| Address |
Datt Mediproducts Pvt Ltd,
56, Community Centre, East of Kailash,
New Delhi, India - 110065
56, Community Center, East of Kailash, New Delhi, Delhi 110065
South
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt Mediproducts Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Pvt Ltd, |
| Address |
56, Community Centre, East of Kailash,
New Delhi, India - 110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Manish Munjal |
Sir Ganga Ram Hospital, New Delhi |
Department of ENT
West
DELHI |
9971149996
may2manish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H748||Other specified disorders of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
Single arm study with no, Comparator |
| Intervention |
VELNEZ |
VELNEZ is a sponge based nasal dressing used after surgery. The dressing is Fragmentable, and biocompatible device. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject eligible for use of VELNEZ as a nasal pack post- nasal surgery.
2. Male and female in an age group of 18 to 80 years, both included.
3. Subjects who can provide written informed consent for participation in the
study.
4. Subjects who allow their data to be collected for the study at predefined
follow-up periods. |
|
| ExclusionCriteria |
| Details |
1.Subject who are unable to be treated with VELNEZ as a nasal packing post-surgery.
2. Subject who cannot provide written informed consent for study data
collection.
3. Subjects unwilling or unable to comply with the postoperative visits necessary
for data collection.
4. Subject with an active infection at the site of surgery.
5. Subject with a history of asthma.
6. Subject who are on aspirin/ anti-platelet drugs.
7. Hypertensive subjects.
8. Subjects who have a history of allergic (Hypersensitive) reactions with any of
the ingredients of the device. (i.e Chitosan, Gelatin and Psyllium husk)
9. Subject with bleeding disorders.
10. Any medical condition that, in the opinion of the investigator, would make the
subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease
that may interfere with the outcome of the study).
11. Subjects with severe inflammation of nasal passages/ sinus cavities.
12. Subjects with a history of prospective recurrent rhino sinusitis and subjects
with bleeding diathesis.
13. Subject found positive for serology.
14. Subject on immunosuppressive drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Study participants who achieve complete hemostasis within 10 minutes of
device application, without any associated adverse events. |
10 minutes of the device application, without any associated adverse events. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Study participants who achieve complete participants within 20 minutes of
device application, without any associated adverse events.
Device fragmentation time in days among all study participants treated with VELNEZ nasal packs.
Study participants having moderate pain.
Study participants experiencing moderate pressure on the surgery site.
Study participants experiencing nasal obstruction, other than the device.
Study participants showing signs of infection at the site of VELNEZ application.
Study participants showing no adhesion to the nasal mucosa on the day of surgery.
Study participants having fluid raised discharge from the nasal cavity. |
14 days ± 2 days from surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
29/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
VELNEZ is a sponge-based biodegradable composite dressing that naturally breaks down within days of application, eliminating the need for removal procedures and reducing associated pain. |