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
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Meril Life Sciences Pvt Ltd
- Enrollment
- 74
- Locations
- 3
- Primary Endpoint
- 1.Airway Patency
Overview
Brief Summary
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
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •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.
- •The Subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations.
Exclusion Criteria
- •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
- •Subjects having symptoms mimicking laryngotracheal stenosis but stenosis not found on CT scan or endoscopy are excluded from the study
- •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
- •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.
- •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.
Outcomes
Primary Outcomes
1.Airway Patency
Time Frame: 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
2.Decannulation
Time Frame: 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
3.Device success
Time Frame: 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 Outcomes
- 1.Shortness of Breathing Score(2. St Georges Respiratory Questionnaire)
Investigators
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd