Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi
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|ClinicalTrials.gov Identifier: NCT03890575|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stricture; Trachea Malignant Neoplasm||Procedure: Airway stent implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Airway Stent for Malignant Stricture
Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.
Procedure: Airway stent implantation
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
- Improvement in Dyspnea using Hugh-Jones classication as criteria [ Time Frame: 3 days ]Hugh-Jones classication: dyspnea scale that includes 5 categories.
- Stent patency time [ Time Frame: 2 months ]Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.
- Overall survival [ Time Frame: 6 months ]OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.
- Number of participants with adverse events that are related to stent implantation [ Time Frame: 2 months ]Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890575
|Contact: Zhongmin Wang, MDemail@example.com|
|Contact: Qungang Shan, MDfirstname.lastname@example.org|
|Ruijin Hospital Luwan Branch||Recruiting|
|Contact: Ju Gong|
|Shanghai Tongren Hospital||Recruiting|
|Contact: Aiwu Mao|
|Principal Investigator:||Zhongmin Wang, MD||Ruijin Hospital|