| CTRI Number |
CTRI/2025/07/092012 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ALRINE Tracheal T-tube enables short term surgical management of tracheal stenosis and the reconstruction of cervical and thoracic trachea. |
Scientific Title of Study
Modification(s)
|
A prospective, single arm, multicenter, observational post-market clinical follow-up study to evaluate the safety and performance of ALRINE(TM) Tracheal T-tube in a real(TM) world setting |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MMI/ALRINE Tracheal T-tube, V2.0.0 dated 11 Jun 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
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
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
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 |
Buiding number 6, 3rd floor, 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 Rahul Rajivkumar Gupta |
Sir Sayajirao General Hospital |
First Floor,ENT and Head-Neck Surgery,Jail Road, Vadodara-390001, India
Vadodara
GUJARAT |
9824403936
doctor.rahul25@gmail.com |
| Dr Rajeev Gupta |
Tender Super speciality Hospital |
Ground Floor ENT Department Tender Super speciality Hospital, Amar Shaheed Path, near Ekana International Cricket Stadium Road, Sector-7, Gomti Nagar, Lucknow, Ahmamau, Uttar Pradesh 226002, India
Lucknow
UTTAR PRADESH |
7834067634
rajevgpta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Sapthagiri Medical College |
Approved |
| Institutional Ethics Committee for Human Research Medical College and SSG Hospital |
Approved |
| Institutional Ethics committee, Atharva Multispeciality Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J042||Acute laryngotracheitis, |
|
|
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.The Subjects who are eligible for the ALRINE™ Tracheal
2.T-tube insertion for laryngeal and tracheal stenosis are included in the study. Subjects with symptoms of breathlessness and stridor and laryngotracheal stenosis confirmed on CT scan are included in the study.
3. The Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent form. If the Subject is not able to write on behalf of the Subject, the Subject`s Legally
acceptable representative (LAR) can fill out the informed consent. When a Subject and LAR are illiterate, a literate impartial witness is required during consenting.
4. The Subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations
|
|
| ExclusionCriteria |
| Details |
1.The Subjects who are not willing to insert an ALRINE™ Tracheal T-tube are excluded from the study.
2.Cancer, or active malignant disease contributing to laryngotracheal stenosis is excluded from the study
3. Subjects having symptoms mimicking laryngotracheal stenosis but stenosis not found on CT scan or endoscopy are excluded from the study
4. Subjects having congenital tracheomalacia, laryngomalacia, vocal cord palsy, laryngeal clefts, congenital cysts, external compression of the airway due to mass lesions or vascular anomalies are excluded from the study
5. Subjects having infections/inflammation-croup,
retropharyngeal abscess, tracheitis, neoplasms-subglottic haemangioma, and recurrent respiratory papillomatosis are excluded from the study.
6.External compression, foreign body.
7. A Subject who is unwilling or unsuitable for postoperative instructions.
8.The Subject who is unwilling or unable to sign the Informed Consent Document will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Airway Patency
2.Decannulation
3.Device success |
1. Time frame: Pre-operative, postoperative, 1 month ± 15 days, 3 months ± 15 days, 6
months ± 15 days
2. Time frame: post-operative, 1 month ±
15 days, 3 months ± 15 days, 6 months ± 15 days
3. Time frame: Intra-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Shortness of Breathing Score
2. St Georges Respiratory Questionnaire
3.Adverse events and serious adverse events
4.Ease of use |
Time frame: Intra operative, Post-operative, 1 month ± 15 days, 3 months ± 15 days, 6 months ± 15 days |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
22/08/2025 |
| 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="6"
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, single arm, multicenter, observational post-market clinical follow-up study to evaluate the safety and performance of ALRINE™ Tracheal T-tube in a realTM world setting
Short Title: ALRINE Tracheal T-tube
Protocol ID, Version & Date: MMI/ALRINE Tracheal T-tube V2.0.0 dated 11-Jun-2025
Study Device: ALRINE™ Tracheal T-tube Indication: Tracheal T-tube used in subjects with tracheal stenosis, postsurgical support, laryngotracheal reconstruction or in cases where prolonged artificial airway access is needed.
Objective: The study aims to evaluate the safety and performance of ALRINE™ Tracheal T-tube in Subjects who undergo prevention and treatment of laryngeal and tracheal stenosis.
Study Design: A prospective, single-arm, multicenter, observational post-market clinical follow-up study.
Rationale of the Study: Critical stenosis of the upper airway not amenable to surgical resection often necessitates a tracheostomy, either as a temporary measure or for long-term relief. A traditional tracheostomy tube does not allow airway remodeling like a silicone rubber T-tube, which occasionally obviates surgical reconstruction. Because of these disadvantages and the potential of additional injury to the trachea from rigid tubes, an alternative solution to maintain a patent physiologic airway is desirable. Hence the tracheal T-tube is designed to overcome these disadvantages. The tracheal T-tube offers a promising alternative for subjects with critical upper airway stenosis that cannot be surgically resected. In some cases, they even eliminate the need for more invasive surgical reconstruction. Bourinet et al. recently analyzed their experience with transcordal silicone stents in adult laryngotracheal stenosis reporting low morbidity and excellent clinical outcomes on long-term follow-up. In addition, some authors reported a successful rate of 100% in cases of web-like stenosis and a few cases of complex stenosis, treated with endoscopic treatment such as laser and stenting. Hence this study is designed to evaluate the safety and performance of tracheal t-tube with a focus on subject comfort, and clinical outcomes in airway management |