CompletedNot Applicable

Management of Complex Airway Stenoses With Dedicated Tailored Stents Wrought by 3D Computer-assisted Conception

France10 participantsStarted 2016-09

Plain-language summary

Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception Dedicated Airway Stents for Central Airway Stenoses DASCAS Toulouse University Hospital is the sponsor of this research. This research will be conducted with the support of AnatomikModeling and ADERSPOT * Background: Tracheobronchial stent are devices designed to manage central airway stenoses of various origins. Their shape and sizes are however not suitable for stenosis of complex anatomy. * Purpose: The investigators propose to test the feasibility and safety of treating complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception Abstract: Central airway obstruction is currently managed with non-personalized stents, which are usually efficient but lead to severe and potentially lethal complications in 10% of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem particularly unsuited for anatomically complex stenosis. Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically improve the tolerance and safety of such prostheses. This first feasibility study, dedicated to patients suffering from anatomically complex stenosis will test the safety of treating patients with these new approach. It should lead to larger studies evaluating these new types of stents in larger indications. After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the same terms as pre-existing models. Close follow up is then conducted, including clinical evaluation after one week, three and six months; spirometry at one week and 6 months and chest CT-scan at one week.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Signature of the informed consent form * Patient with a complex upper airway stenosis . * Symptomatic stenosis ( Dyspnea \> NYHA II , cough, PEF \< 50%) * Stenosis whose complex anatomy does not allow the establishment of a currently available stent on the market: the assessment of the experts ( consensus decision between 3 bronchoscopistes of interventional endoscopy service) or after failure of one or several models. * Affiliated with a social security scheme Exclusion Criteria: * Indication of implementation of emergency aid : signs of acute respiratory distress , PEF \< 20 % predicted , SpO2 oxygen saturation \<90 % on room air * Contraindication to rigid bronchoscopy (severe coagulation disorders not correct ) * Patient under legal protection system * Pregnancy * Breastfeeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of percentage of procedures conducted without complications at 1 week , 3 months and 6 months

Timeframe: Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months

Trial details

NCT IDNCT02889029

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Obstructive Airway Disease trials