| CTRI Number |
CTRI/2025/02/081421 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the effectiveness of a nasal pack (VELNEZ®) used as a dressing after a nasal surgery in pediatric patients (5 to 17 years) |
|
Scientific Title of Study
|
A multi-centric, non-randomized, post-marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ® as a nasal pack after nasal surgery in pediatric age group (5 to 17 years). |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DMPL/CIP-004-2025/CT/VN, version 2.0, Date 01-May-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
S.N Medical College, Agra |
| Address |
Department of ENT & Head Neck surgery, S.N Medical College, Agra
Agra
UTTAR PRADESH
282002
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
dr.akhilpratapsingh1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice president & Head R and D |
| Affiliation |
Datt Mediproducts Pvt. Ltd. |
| Address |
Datt Mediproducts Pvt Ltd
52 to 54,63 and 64, Roz Ka Meo Industrial Area Nuh, Distt. Mewat
Gurgaon
HARYANA
122103
India |
| Phone |
7290073669 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
PANKAJ BABLANI |
| Designation |
GM Clinical Research Operations |
| Affiliation |
Datt Mediproducts Pvt. Ltd. |
| Address |
Datt Mediproducts Pvt. Ltd.
56, Community Center, East of Kailash, New Delhi
New Delhi
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt Mediproducts Pvt. Ltd. is the sponsor in the trial.
having its office located at, 56 Community Center, East of Kailash, New Delhi- 110065, India.
The trial will also be insured |
|
|
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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumeet Angral |
AIIMS, Bilaspur, Himachal Pradesh |
Department of ENT
AIIMS, Bilaspur, Changar Palasiyan, Noa, Himachal Pradesh
Bilaspur
HIMACHAL PRADESH |
9560564977
angralsumeet@gmail.com |
| Dr Shama Bellad |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Department of ENT
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi, Karnataka.
Belgaum
KARNATAKA |
9742022312
shamadarsh@gmail.com |
| Dr Akhil Partap Singh |
S.N. Medical College,, Agra |
Department of ENT
S.N. Medical College, Moti Katra,
Agra - 282002
Agra
UTTAR PRADESH |
7895464858
dr.akhilpratapsingh1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE CLINICAL TRIALS,, AIIMS, Bilaspur |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE, KLE University |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, SN Medical College, Agra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
NA |
| Intervention |
VELNEZ a nasal pack |
is a biodegradable composite that fragments within few days on application and intended as nasal pack.
Duration of trial is 1 year. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject eligible for the use of VELNEZ as a nasal pack in routine clinical practice after planned nasal surgeries such as septoplasty, turbinoplasty, polyp and other nasal surgery.
2. Male and female children in the age group of 5 to 17 years. (Both Included)
3. Subjects whose parents or legally authorized representatives (LAR) can provide written informed consent and, where applicable, subjects who can provide assent in accordance with regulatory requirements.
4. Subjects whose parents or legally authorized representatives (LAR) are willing to allow the collection of their child’s study data at predefined follow-up periods. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are unable to be treated with VELNEZ as a nasal packing in routine clinical practice following planned surgery.
2. Subjects whose parents or legally authorized representatives (LAR) cannot provide written informed consent, or subjects unable to provide assent where applicable.
3. Subjects testing positive for HIV, HBsAg, or HCV.
4. Subjects unwilling or unable to comply with the necessary postoperative visits for data collection.
5. Subjects with an active infection at the surgical site.
6. Subjects with a history of unstable asthma.
7. Subjects currently on aspirin or antiplatelet therapy, or those with bleeding disorders.
8. Hypertensive subjects.
9. Subjects with a history of allergic (hypersensitivity) reactions to any ingredients of the device (VELNEZ) such as Chitosan, Gelatin, or Psyllium husk.
10. Subjects with any medical condition that, in the opinion of the investigator, would make them unsuitable for inclusion (e.g., chronic, relapsing, or hereditary diseases that may interfere with the study outcomes).
11. Subjects with severe rhinosinusitis involving all paranasal sinuses, associated with Sinonasal polyposis, Allergic fungal rhinosinusitis, Gross septal deviation or spurs impinging on the ostiomeatal complex (OMC),Large concha bullosa, or Allergic turbinate hypertrophy in contact with the septum.
12. Subjects with a history of postoperative recurrent rhinosinusitis or bleeding diathesis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The primary endpoint will be achieved if the following criteria are met:
1. Study participants achieve complete cessation of reactive and secondary bleeding within 20 minutes post-application of VELNEZ.
2. Study participants tolerate the use of VELNEZ as a nasal pack, with no significant safety concerns reported during the study.
|
60±5 days from device application |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Absence of post-operative adhesions at the surgical site following the use of VELNEZ.
2. Effectiveness of VELNEZ in promoting coagulation as assessed through clinical observation.
3. Monitoring & reporting of any adverse events associated with the application of VELNEZ throughout the study.
4. Evaluation of pain levels throughout the study
5. Change in the Parameters assessed by endoscopy examination.
6. Assessment of changes in Nasal Obstruction Symptom Evaluation (NOSE score) to determine improvements in nasal symptoms & overall quality of life. |
60±5 days from device application |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 nasal pack, manufactured and marketed by Datt Mediproducts Private Limited, offers a novel solution as a biodegradable composite nasal dressing. It fragments naturally within a few days of application (3-5 days), obviating the need for painful removal. VELNEZ is designed to provide effective hemostasis, reduce fibrosis, and promote healing while minimizing patient discomfort. By eliminating the risks associated with traditional nasal packing methods, VELNEZ holds significant promise as a safer and more tolerable alternative for pediatric patients. The rationale for this multi-centric, non-randomized post-marketing surveillance study is to evaluate the safety and tolerability of VELNEZ in pediatric patients (aged 5 to 17 years) undergoing nasal surgery. The study will assess its efficacy in ceasing reactive and secondary bleeding, its non-adhesive properties, and its overall safety profile based on adverse event reporting. Additionally, the study aims to evaluate patient-reported outcomes such as pain levels using, Visual Analog Scale, Breathing effect by Nasal
Obstruction Symptom Evaluation (NOSE Score
) And an Endoscopy examination throughout the Study. Through this study, we aim to generate robust post-marketing data that will further validate the clinical benefits of VELNEZ in this vulnerable population, ensuring its safe and effective use in routine clinical practice. |