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CTRI Number  CTRI/2021/09/036437 [Registered on: 13/09/2021] Trial Registered Prospectively
Last Modified On: 26/05/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A study (PMS) to check and assess the safety and tolerability of a biodegradable nasal dressing (VELNEZ) after nose surgery. 
Scientific Title of Study   A post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as nasal pack after nasal surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DMPL/CIP-002-2021/CT/VN  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhil Partap Singh 
Designation  Associate Professor  
Affiliation  Sarojini Naidu Medical College 
Address  Department of ENT, Sarojini Naidu Medical College, Agra- 282002. (U.P)

Agra
UTTAR PRADESH
282002
India 
Phone  7895464858  
Fax    
Email  researchsnmc111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhil Partap Singh 
Designation  Associate Professor  
Affiliation  Sarojini Naidu Medical College 
Address  Department of ENT, Sarojini Naidu Medical College, Agra- 282002. (U.P)

Agra
UTTAR PRADESH
282002
India 
Phone  7895464858  
Fax    
Email  researchsnmc111@gmail.com  
 
Details of Contact Person
Public Query  
Name  PANKAJ BABLANI 
Designation  Head Clinical Operations 
Affiliation  Datt Mediproducts Pvt. Ltd 
Address  Datt Mediproducts Pvt. Ltd. 56 Community Centre, East of Kailash, New Delhi-110065

South
DELHI
110017
India 
Phone  9999059412  
Fax    
Email  pankajbablani@gmail.com  
 
Source of Monetary or Material Support  
Datt Mediproducts Pvt. Ltd. 56 Community centre, East of Kailash. New Delhi-110065 
 
Primary Sponsor  
Name  Datt Mediproducts Pvt Ltd 
Address  56 Community centre, East of Kailash. New Delhi-110065 
Type of Sponsor  Other [Medical Device company- Indian] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  N/Ap 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhil Partap Singh  Department of ENT, S.N Medical college  Department of ENT, Room No. 2, 4th floor, New surgical building. Sarojini Naidu Medical College, Moti Katra. Agra - 282002 (U.P)
Agra
UTTAR PRADESH 		 7895464858

researchsnmc111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee S.N Medical College, Agra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  VELNEZ  VELNEZ is intended to be used as a nasal pack after the nasal surgery (either for Septoplasty or Turbinoplasty). It prevents adhesion by separating the compromised mucosal surfaces and also helps in healing and achieving haemostasis). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after
planned surgery (either for septoplasty or turbinoplasty).
2. Male and female of age group between 18 to 60 years.
3. Subjects who can provide informed consent form in writing to provide data for the
study.
4. Subjects who allow their data to be collected for the study at predefined follow-up
periods.
 
 
ExclusionCriteria 
Details  Subject who unable to treat with the VELNEZ as a nasal packing in routine clinical
practice after planned surgery.
2. Subject who cannot provide written informed consent for 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 planned surgery site.
5. Subject with a history of asthma.
6. Subject who are on aspirin or anti-platelet drugs therapy.
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 etc.
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 rhinosinusitis involving all the paranasal sinuses associated
with sinonasal polyposis, allergic fungal rhinosinusitis, gross septal deviation or
spurs hitching on the ostiomeatal complex (OMC) region huge concha bullosa or allergic turbinate hypertrophy in contact with septum.
12. Subjects with a history of prospective recurrent rhinosinusitis and subjects with bleeding diathesis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Study participants who achieve complete hemostasis with 20 minutes without any
associated adverse events. 		 20 minutes of VELNEZ application. 
 
Secondary Outcome  
Outcome  TimePoints 
Study participants having moderate pain.
Study participants having moderate obstructionStudy participants having infection at the site of VELNEZ application.
Study participants with no adhesion.
Study participants having Pressure effect due to VELNEZ Application.
Study participants having fluid discharge volume. 		 28 days of patient follow-up (10 Visits) 
 
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)   15/09/2021 
Date of Study Completion (India) 24/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not done till date 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Functional endoscopic sinus surgery (FESS) has today become the norm in chronic rhinosinusitis, which provides successful results world-over. Nasal packs which have recently emerged in the Indian scenarios are found to be more user-friendly, equally effective for haemostasis and less traumatic to the operated nasal mucosa. VELNEZ nasal pack manufactured and marketed by Datt Mediproducts Private Limited is a biodegradable composite that fragments within few days on the application intended as nasal dressing. The pain associated with the traditional nasal pack removal is completely eliminated with VELNEZ since removal procedures is not necessary on the application of VELNEZ. Also reduces fibrosis at the same time promotes healing and clotting. The rationale of this study is to assess the safety and tolerability of VELNEZ as a nasal pack in subjects undergoing for planned nasal surgery.  
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