| CTRI Number |
CTRI/2025/09/095271 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MyNasal Internal Nasal Bi-valve Splints |
|
Scientific Title of Study
|
MyNasal Internal Nasal Bi-Valve Splints-A prospective, multi-center, observational, real world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal(TM) Internal Nasal Bi-valve Splints |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MMI/MyNasal Internal Nasal Bi-valve Splints V3.0.1 08-7-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Medical Innovations Pvt. Ltd, Survey no 1574, Bilakhia House, Muktanand Marg, Chala, Vapi, Valsad, Gujarat, 396191, India |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Virendra Ghaisas |
Ghaisas ENT Hospital |
1248 B, NH 753F, Next to Ground Floor, ENT and Rhinoplasty Surgery, Raymond Showroom, Pulachi Wadi, Deccan Gymkhana, Pune-411004, Maharashtra, India. Pune MAHARASHTRA
Pune
MAHARASHTRA |
9850958382
virendraghaisas@gmail.com |
| Dr Heer Patel |
Life Care Institute of Medical Sciences & Research |
ENT and HEAD and NECK SURGERY, Third Floor,Sardar Patel Statue Corner, Stadium Road, Ahmedabad-380 014 Gujarat, India
Ahmadabad
GUJARAT |
9924512333
drheerent@gmail.com |
| Dr Abhijit Mantri |
MTES’s Sanjeevan Hospital |
Ground Floor ENT Department PLOT NO. 23, OFF Karve Road Erandawane, Pune
Pune Maharashtra - 411004
Pune
MAHARASHTRA |
9822096460
mantri_a@rediffmail.com |
| Dr Rajendran Dinesh Kumar |
Raja Rajeswari Medical College and Hospital |
Ground Floor ENT Department 202, Mysore Road, Kambipura, Bengaluru, Karnataka-560030, India
Bangalore
KARNATAKA |
9620928650
dinuraj1186@gmail.com |
| Dr KG Somashekara |
Sapthagiri Institute of Medical Sciences and Research Centre |
1st Floor, ENT Department, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090, India
Bangalore
KARNATAKA |
9844024597
cepodemxp@gmail.com |
| Dr Shweta Gogia |
Sir Ganga Ram Hospital |
Rajindcr Nagar, New Delhi, India
New Delhi
DELHI |
9818966277
drshwetagogia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Institution Ethics Committee Sapthagiri Medical College |
Approved |
| Institutional Ethics committee Rajarajeswari Medical College and Hospital |
Approved |
| MTES’s SANJEEVAN HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| Shakti Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal support shall be included.
2. Subjects across different age groups who require post-surgical splinting
of the nasal septum and would be treated with MyNasal Internal Nasal
Bi-valve Splints.
3. Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
4. Subject is willing and able to comply with post-operative scheduled
clinical evaluations shall be included.
5. Subject for whom the treating surgeon deems that internal nasal splints are required to maintain nasal patency and prevent septal hematoma, adhesion formation, or collapse post-surgery shall be included. |
|
| ExclusionCriteria |
| Details |
1. Subject any known sensitivity or allergy to silicone or any material used
in the splint will disqualify a participant from the trial shall be excluded.
2. Subjects with active nasal infections or untreated chronic sinusitis shall
be excluded.
3. Subjects undergoing revision surgery for failed nasal reconstruction shall
be excluded.
4. Subjects with coagulopathy or bleeding disorders, or those taking
anticoagulant or antiplatelet treatment that may affect with clot formation
and wound healing will be excluded shall be excluded.
5. Subject presents with recent or acute nasal trauma or fractures that
necessitate more sophisticated surgical treatments than the splints are
insufficient to support the healing and will be excluded shall be excluded.
6. Subjects who have undergone previous nasal surgeries involving the insertion of permanent devices may have difficulty with bi- valve splints. These splints may be difficult to insert or remove due to the presence of such device and shall be excluded.
7. Pregnant women will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Nasal airway patency
2. Structural Support and Stability
3. Bleeding and hematoma |
1. Time frame: Pre-operative and postoperative
2. Time frame: Post-operative, 7 days ± 2 days, 15 days ± 2 days
3. Time frame: Pre-operative, Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hematoma formation
2. Adhesion formation
3. Visual analog scale
4. Complication and AE/SAE
5. Ease of use
6. Nasal Obstruction Symptom Evaluation (NOSE)
7. Removal of Splint time |
1.Time frame: Post-operative , 7 days ± 2 days, 15 days ± 2 days, 30 days ± 15 days, 3 months ± 15 days
2. Time Frame: 7 days ± 2 days, 15 days ± 2 days,
and 30 days ± 7 days, 3 months ± 15 days
3.Time Frame: Pre-operative, Postoperative, 7 days ± 2 days, 15 days ± 2 days, 30 days ± 15 days and 3 months ± 15 days
4. Time Frame: Intra and Post-operative,
7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days and 3 months ± 15 days
5. Time Frame: Intra operative, 7 days ± 2 days, 15 days ± 2 days
6.Time Frame: Preoperative, Post-operative, 7 days ± 2 days, 15 days ± 2 days, 30 days
± 7 days and 3 months ± 15 days
7.Time frame: 7 days ± 2 days to 15 days ± 2 days |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
15/10/2025 |
| 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="0"
Months="3"
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)
|
Title: MyNasal Internal Nasal Bi-Valve Splints-A prospective, multi-center, observational, real world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal(TM) Internal Nasal Bi-valve Splints
Protocol ID, Version & Date: MMI/MyNasal Internal Nasal Bi-valve Splints Version 2.0.0_03-Feb-2025
Study device : MyNasal™ Internal Nasal Bi-valve Splints Indication Internal Nasal Bi-Valve splints are indicated to provide vital septal support and prevent adhesions between the septum and lateral nasal wall. Objective The objective of this study is to evaluate the safety and performance of MyNasal Internal Nasal™ Bi-valve Splint in nasal surgeries or procedures to provide vital septal support and prevent adhesions between the septum and lateral nasal wall.
Study Design: A prospective, multi-centers, observational, real-world, clinical investigational study.
Rationale of the Study :The study aims to evaluate the use of nasal splints is a standard practice in nasal surgeries or procedures to support and stabilize the nasal passages during the healing process. These devices are critical in maintaining structural integrity, minimizing complications, and improving patient outcomes. However, the safety and performance of specific devices in real-world settings require rigorous evaluation to ensure their efficacy and tolerability across diverse patient populations. The MyNasal™ Internal Nasal Bi-valve Splints are designed to use nasal surgeries or procedures to support and stabilize the nasal passages during the healing process. This study aims to evaluate the safety and performance of MyNasal Internal Nasal Bi-valve Splints in real-world clinical settings |