Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
1 other identifier
interventional
100
1 country
2
Brief Summary
In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 11, 2020
February 1, 2020
5.6 years
March 19, 2019
February 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Improvement in Dyspnea using Hugh-Jones classication as criteria
Hugh-Jones classication: dyspnea scale that includes 5 categories.
3 days
Stent patency time
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.
2 months
Overall survival
OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.
6 months
Secondary Outcomes (1)
Number of participants with adverse events that are related to stent implantation
2 months
Study Arms (1)
Airway Stent for Malignant Stricture
EXPERIMENTALPatients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.
Interventions
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
Eligibility Criteria
You may qualify if:
- Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.
You may not qualify if:
- Severe infection
- Coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Shanghai Pulmonary Hospital, Shanghai, Chinacollaborator
- Shanghai Tong Ren Hospitalcollaborator
- Ruijin Hospital Luwan Branchcollaborator
Study Sites (2)
Ruijin Hospital Luwan Branch
Shanghai, China
Shanghai Tongren Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongmin Wang, MD
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 26, 2019
Study Start
April 1, 2017
Primary Completion
November 1, 2022
Study Completion
December 31, 2022
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share