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CTRI Number  CTRI/2025/04/084390 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   MyNasal INA Splints 
Scientific Title of Study
Modification(s)  		 A prospective, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal(TM) Internal Nasal Airway Splints. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MMI/MyNasal INA Splints, V3.0.1 dated 08-Jul-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  Meril Life Sciences Pvt. Ltd, 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  Meril Life Sciences Pvt. Ltd, 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  Meril Life Sciences Pvt. Ltd, 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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Virendra Ghaisas  Ghaisas ENT Hospital  1248 B, NH 753F, Next to Raymond Showroom, Pulachi Wadi, Deccan Gymkhana, Pune-411004, Maharashtra, India.
Pune
MAHARASHTRA 		 9850958382

virendraghaisas@gmail.com 
DrHeer Patel  Life Care Institute of Medical Sciences & Research  ENT and HEAD & NECK SURGERY, Third Floor,Sardar Patel Statue Corner, Stadium Road, Ahmedabad-380 014 Gujarat, India
Ahmadabad
GUJARAT 		 9924512333

drheerent@gmail.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 K G Somashekara  Sapthagiri Institute of Medical Sciences and Research Centre  ENT Department, 1st floor, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090, India
Bangalore
KARNATAKA 		 9844024597

cepodemxp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Independent Ethics Committee  Approved 
Institution Ethics Committee Sapthagiri Medical College  Approved 
Institutional Ethics committee Rajarajeswari Medical College and Hospital  Approved 
Shakti Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. Subjects across different age groups who require postsurgical splinting of the nasal septum and treated with MyNasal™ Internal Nasal Airway Splints.
2. Subject who has been provided written informed
consent.
3. Subject who agreed to undergo all clinical
investigations and follow-up visits as per protocol requirements.
4. Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal
5. Subject who required maintaining support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures, maintain open airways for better airflow, and facilitate drainage of nasal secretions. 
 
ExclusionCriteria 
Details  1. Subjects with a history of respiratory tract infection and nasal decongestant use within 1 month before the visit
2. Pregnant or lactating women.
3. Subject with a history of craniocerebral and nasal surgery.
4. Subject any known sensitivity or allergy to silicone or any material used in the splint.
5. Subjects with active nasal infections or untreated chronic sinusitis.
6. Subjects undergoing revision surgery for failed nasal reconstruction.
7. Subjects with coagulopathy or bleeding disorders, or those taking anticoagulant or antiplatelet treatment that may affect with clot formation and wound healing.
8. 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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Nasal obstruction
2. Complications and AE/SAE related to device
3. Structural Support and Stability
4. Nasal Airway Patency 		 1. Time Frame: Baseline, postoperative, 30 days ± 7 days, 3 months ± 15 days
2. Time
Frame: Intra-operative, 7 days ± 2 days, 30 days ±7 days, 3 months ± 15 days
3.Time frame:
post-operative, 7 days ± 2 days, 30 days ± 2 days
4. Time frame: Pre-operative
and post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pain and discomfort
2. Nasal airflow
3. Change in Quality of Life
4. Ease of use
5. Removal of Splint time 		 1. Time Frame: Baseline, postoperative, 7 days ± 2 days, 30 days ± 7 days, 3
months ± 15 days
2. Time Frame: Post-operative, 7 days± 2 days, 30 days ± 7 days, 3 months ± 15 days
3.Time Frame: Baseline, 7
days ± 2 days, 30 days ± 7 days, 3 months ± 15 days
4. Time Frame: Intra-operative and 7 days ± 2 days
5. Time Frame: 7 days ± 2
days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/04/2025 
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)  		 Study name: A prospective, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of MyNasal™ Internal Nasal Airway Splints..

 Protocol Number, Version, and Date: MMI/MyNasal INA Splints, V3.0.1 dated 08-Jul-2025 

Indication: Nasal splints are used to support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures, maintain open airways for better airflow, and facilitate drainage of nasal secretions. 

Study Objectives: The objective of this study is to evaluate the safety and performance of MyNasal™ Internal Nasal Airway Splints in Subjects who require post-surgical splinting of the nasal septum in septoplasty and rhinoplasty.

 Study Design: A prospective, multi-center, observational, real-world, Post marketing clinical follow-up study. 

Rationale of the Study: The rationale for conducting a prospective study on MyNasal™ Internal Nasal Airway Splints in real-world settings is to comprehensively evaluate their clinical effectiveness and impact on Subject outcomes outside of controlled environments. This study aims to assess not only the improvement in nasal airflow but also the comfort and compliance of Subjects using these splints, recognizing that experiences may vary in everyday clinical practice. Additionally, the investigation will focus on the safety profile of the splints, identifying any complications or adverse effects that may arise in diverse Subject populations. Furthermore, it will track long-term outcomes to understand the sustained benefits or potential drawbacks of splint usage, providing insights into their role in ongoing nasal health management. Lastly, analyzing resource utilization, including costs and recovery times, will help optimize treatment protocols and enhance overall Subject care in Ear, Nose, and Throat practices. 
 
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