| CTRI Number |
CTRI/2025/04/085351 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| 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 Pre-cut Splints |
Scientific Title of Study
Modification(s)
|
A prospective, open-label, multi-center, post market clinical follow-up study to evaluate the safety and performance of MyNasal (TM) Internal Nasal Pre-cut Splints. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MMI/ MyNasal Internal Nasal Pre-cut V3.0.1 dated 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 |
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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVirendra Ghaisas |
Ghaisas ENT Hospital |
ENT and Rhinoplasty Surgery, Ground Floor,1248 B, NH 753F, Next to Raymond Showroom, Pulachi Wadi, Deccan Gymkhana, Pune-411004, Maharashtra, India.
Pune
MAHARASHTRA |
9850958382
virendraghaisas@gmail.com |
| Dr Heer 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 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 |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| 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 |
| 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
Modification(s)
|
| 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 Pre-cut Splints.
2.The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form.
3.When a Subject and LAR (Legally acceptable representative) are illiterate, a literate impartial witness is required during consenting.
4.If the Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent.
5.The Subject should be able to comply with protocol requirements and assessments.
6.Subjects requiring short-term post-surgical splinting of the nasal septum after procedure such as septoplasty, rhinoplasty, turbinate reduction, functional or cosmetic surgeries that necessitate internal nasal pre-cut splints
7.Subjects with conditions required nasal stabilization to prevent septal hematoma or adhesion formation post surgery.
8.Subjects with normal healing capacity and without contraindications to nasal surgeries.
|
|
| ExclusionCriteria |
| Details |
1. Without informed consent, the Subject is not eligible for the study.
2. Any sign of infection at the time of operation.
3. Previous history of any type of nasal surgery.
4. Any known hypersensitivity or allergic reaction to silicone or similar materials.
5. Subjects with severe nasal deformities or obstructions that make placement of the splint unfeasible.
6. Subjects with bleeding disorders that affect wound healing or increase surgical risks.
7. Women who are pregnant or breastfeeding.
8. Subjects with a known or suspected Cerebrospinal Fluid leak, as this condition may complicate the use of nasal pre-cut splints and increase the risk of postoperative complications such as infection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain score
2. Nasal Airway patency
|
1.Time Frame: Pre and Post-operative, 7 days ± 2 days, 15 days ± 2 days, 1-month ± 7 days follow-up and 3-month ± 15 day follow-up
2.Time frame: Pre-operative and Post-operative
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total Operative time
2. Quality of life
3. Removal of Splint time
4. Mucosal healing after surgery
5. Structural Support and Stability
6. Complication and AE/SAE related to device
7. Ease of use
|
1. Time Frame: Intra-operative
2. Time Frame: Pre-operatively, Post-operatively, 7 days ± 2 days, 15 days ± 2 days, 1 month± 7 days and 3 months ± 15 days follow-up
3. Time Frame : 7 days ± 2 days
4. Time frame: Postoperative, 7 days ± 2 days, 15 days ± 2 days, 1 month± 7 days and 3 months ± 15 days
5. Time frame: Postoperative, 7 days ± 2 days, 15 days ± 2 days
6. Time Frame: Intra and post-operative, 7 days ± 2 days, 15 days ± 2 days, 1-month± 7 daysfollow-up and 3-month ± 15 days follow-up
7. Time Frame: Intra-operative, 7 days ± 2 days
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
29/04/2025 |
| 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, open-label, multi-center, post market clinical follow-up study to evaluate
the safety and performance of MyNasal™ Internal Nasal Pre-cut Splints. Protocol ID, Version & Date: MMI/ MyNasal Internal Nasal Pre-cut Splints, V3.0.1 dated 08-Jul-2025
Study Device: MyNasal™ Internal Nasal Pre-cut Splints
Indication: The MyNasal™ Internal Nasal Pre-cut Splints are indicated to be used to support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures and facilitate drainage of nasal secretions.
Objective: The aim of the study is to evaluate the safety and performance of MyNasal™ Internal Nasal Pre-cut Splints.
Study Design: A prospective, open-label, multi-center, post market clinical follow-up study .
Rationale:
Nasal septal surgery is one of the most frequently performed procedures in otorhinolaryngology, often conducted either on its own or in combination with other surgeries. Nasal packing is widely regarded as one of the most effective methods for providing septal support and preventing adhesions following nasal surgery. It is commonly used in various endonasal procedures, such as septoplasty, turbinectomy, and sinus surgeries, to prevent complications like synechiae and hematoma. Nasal packing materials serve multiple purposes, including supporting the alignment of septal flaps and closing spaces between cartilage and subperichondrial flaps. Postoperatively, different types of nasal packing are utilized, including medicated or non-medicated gauzes, Telfa, foam, absorbable gelatin sponges, merocel, silicone nasal splints, and polyethylene oxide gel. These risks can be minimized by employing nasal splints and selecting the most suitable packing materials. Internal nasal splints are designed to provide structural support and minimize postoperative complications, addressing the limitations of traditional nasal packing materials like merocel and gauze, which can cause discomfort and mucosal injury. The aim of study to evaluate the safety and performance of the MyNasal™ Internal Nasal Splint Pre-Cut in clinical practice. |