NCT05334199|Completed
Biodegradable Airway Stent Post Lung Transplant
Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication
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Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication
Sponsor study identifier
interventional
20
1 country
2
Study Start
April 2, 2019
Actual (reported)Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)Introduction and rationale Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent. Research question
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2019
Actual (reported)March 31, 2022
Actual (reported)March 31, 2022
Actual (reported)March 31, 2022
Actual (reported)April 19, 2022
Actual (reported)Adverse events
Adverse events associated with airway stents
4 months after placement
Change in FEV1
1 week post placement
Change in FVC
1 week post placement
Time to need for new stent placement
6 months after placement
Biodegradable stent treatment group
Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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AMC
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
Dirk-Jan Slebos, MD, PhD
University Medical Center Groningen
20 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2022
First Posted
April 19, 2022
Study Start
April 2, 2019
Actual (reported)Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)Last Updated
April 27, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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