| CTRI Number |
CTRI/2025/03/082108 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Post-marketing study, (PMCF) to check the safety and tolerability of VELNEZ® a space-occupying ear dressing used to stop ear bleading after ear surgery. |
|
Scientific Title of Study
|
A single centric, open label, single arm, post marketing clinical follow-up (PMCF) study to evaluate safety and tolerability of VELNEZ®- A space occupying dressing after ear surgery. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DMPL/CIP-007-2024/CT/VN, Version 1.0, Dated, 11-Jun-2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gaurav Shankar Medikeri |
| Designation |
ENT surgeon |
| Affiliation |
Medikeris Super Speciality ENT Center, Bengaluru, Karnataka |
| Address |
9/91, Govindappa Cross, R.V road, Bengaluru.
Bangalore
KARNATAKA
560004
India |
| Phone |
9880675446 |
| Fax |
|
| Email |
gauravsmedikeri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice President and HOD R&D |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
52,53,54,63 and 64 Rojka Meo, Industrial Area, Distt. Nuh
Gurgaon
HARYANA
122103
India |
| Phone |
9871011002 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
PANKAJ BABLANI |
| Designation |
G M Clinical Research Operations |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
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,
56, Community Centre, East Of Kailash, New Delhi, Delhi 110065 |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Pvt Ltd |
| Address |
56, Community Center, East of Kailash, New Delhi, Delhi 110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Shankar Medikeri |
Medikeris Super Speciality ENT Center, Bengaluru, Karnataka. |
9/91, Govindappa Cross, R.V road, Bengaluru.
Bangalore
KARNATAKA |
9880675446
gauravsmedikeri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Prakriya Hospital Institutional Ethics Committee |
Approved |
| Sapthagiri Institute of medical Sciences and Research Center Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
VELNEZ® |
VELNEZ® is a single timed used dressing pack designed to be placed in the ear canal to stop ear-bleeding, post ear surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject for the use of VELNEZ® as a dressing pack in a routine clinical practice after a planned otologic surgery. (Tympanoplasty or Myringoplasty or any other middle ear surgeries)
2. Male and female in the age group of 18 to 60 years, (Both Included).
3. Subjects who can provide informed consent form in writing or through his/her LAR.
4. Subjects who allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives. |
|
| ExclusionCriteria |
| Details |
1. Subject who are unable to be treated with the VELNEZ® as a dressing packing in routine clinical practice after a planned surgery.
2. Subject who cannot provide written informed consent for data collection.
3. Subject unwilling or unable to comply with the postoperative visits necessary for data collection.
4. Subject with a sign of active infection at the site of surgery.
5. Subject with uncontrolled cholesteatoma, malignant tumors, complications of chronic ear disease.
6. Subject who are on aspirin or anti-platelet drugs therapy.
7. Pregnant and nursing women.
8. Subject with uncontrolled hypertensive subjects.
9. Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ®) i.e., Chitosan, Gelatin and Psyllium husk etc.
10. Subject with bleeding disorders.
11. 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).
12. Subject with history of postoperative recurrent infections and subjects with bleeding diathesis.
13. Subject found to be positive in serology.
14. Subject on immunosuppressive drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of adverse events reported that directly attributes to the use of VELNEZ® as an ear dressing.
2. Incidence of post-operative primary and secondary bleeding during the conduct of the study.
3. Proportion of study participants achieving degradation of the VELNEZ® dressing within 28±2 days post-application.
4. Proportion of study participants achieving degradation of the VELNEZ® dressing within 60±5 days post-application |
Degradation of Ear dressing (VELNEZ) achieved in 28±2 days & 60±5 days (i,e 4 weeks & 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of moderate to severe pain reported by study participants by visit 09/end of study visit.
2. Occurrence of signs of infection at the site of VELNEZ® application among study participants.
3. Observation of absence of adhesion of VELNEZ® dressing during the removal in study participants (in case device is not dissolved within 60±5 days).
4. Measurement of increased pressure effect in the ear canal attributed to VELNEZ® application during study visits. |
2 months (60 days±5 days) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
VelNez® is a biodegradable, self-dispersive ear dressing developed by Datt Mediproducts for use after ear surgeries such as Tympanoplasty and Myringoplasty. It provides effective hemostasis within 20 minutes and naturally degrades in 20–25 days, avoiding the need for painful removal. By eliminating risks linked to traditional packing methods, VelNez® offers a safer, more tolerable alternative for postoperative care. It is specifically indicated for bleeding control and adhesion prevention in external and middle ear procedures, ensuring improved patient comfort and reducing post-surgical complications. |