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CTRI Number  CTRI/2025/02/080933 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 30/08/2025
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 clinical study to evaluate safety and tolerability of VELNEZ as a space occupying dressing 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  
Secondary ID  Identifier 
DMPL/CIP-005/2024/CT/VN  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Chandra Agarwal 
Designation  Additional Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences 
Address  Department of ENT, Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, UP – 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  9663558322  
Fax    
Email  ashishchandraagarwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth Pandey 
Designation  VP and Head R and D 
Affiliation  Datt Mediproducts Pvt Ltd 
Address  Department of R&D, 52-54,63 & 64, Roz Ka Meo Industrial Area Nuh, Distt. Mewat

Gurgaon
HARYANA
122103
India 
Phone  9871011002  
Fax    
Email  siddharth.pandey@dattmedi.com  
 
Details of Contact Person
Public Query  
Name  PANKAJ BABLANI 
Designation  Head Clinical Research Operations 
Affiliation  Datt Mediproducts Pvt Ltd.  
Address  Department of Clinical Research 56, Community Center, East of Kailash, New Delhi, Delhi 110065
56, Community Center, East of Kailash, New Delhi, Delhi 110065
South
DELHI
110065
India 
Phone  9315785417  
Fax    
Email  PANKAJBABLANI@GMAIL.COM  
 
Source of Monetary or Material Support  
The trial would be conducted in the ENT department of RML hospital, Lucknow. VELNEZ will be provided by the sponsor  
 
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  
Name  Address 
NA  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Chandra Agarwal  Dr Ram Manohar Lohia Institute of Medical Sciences  Department of ENT Dr R M L, Institute of Medical Sciences Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH 		 9663558322

ashishchandraagarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr RML, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H74||Other disorders of middle ear mastoid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Velnez  A space occupying dressing USED after 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 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    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events reported that directly attributes to the use of VELNEZ as an ear dressing.
Incidence of post-operative primary and secondary bleeding during the conduct of the study.
Proportion of study participants achieving degradation of the VELNEZ dressing within 28 days post-application.
Proportion of study participants achieving degradation of the VELNEZ dressing within 60 days post-application. 		 Up-yo 65 days post dressing 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of moderate to severe pain reported by study participants by visit 11/end of study visit.
Occurrence of signs of infection at the site of VELNEZ application among study participants.
Observation of absence of adhesion of VELNEZ dressing during the removal in study participants (in case device is not dissolved within 60 days).
Measurement of increased pressure effect in the ear canal attributed to VELNEZ application during study visits. 		 Up-to 65 days post dressing 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   28/02/2025 
Date of Study Completion (India) 19/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/08/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 an ear dressing that is biodegradable and is designed to disintegrate within a few days of application. This feature eliminates the need for painful dressing removal procedures associated with traditional packs. Furthermore, VELNEZ aids in reducing fibrosis and also promotes healing and clotting, thereby facilitating a smoother recovery process for patients undergoing middle ear surgeries. 
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