Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
1 other identifier
interventional
100
1 country
2
Brief Summary
In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi 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 Mar 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
March 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
5.7 years
March 19, 2019
February 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Relief of symptoms
Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
1 month
Heal of fistula
The heal of fistula confirmed by gastroscopy, bronchoscopy and CT
3 months
Secondary Outcomes (2)
Number of participants with adverse events that are related to stent implantation
6 months
Stent patency time
6 months
Study Arms (1)
Segmented Airway Stent for Gastro-Respiratory fistula
EXPERIMENTALSegmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula.
Interventions
The segmented airway stent modified with 3D printing were implanted to treat gastro-respiratory fistula involving carina and distal bronchi. The stents were removed because of stent-related complications or tracheobronchial healing.
Eligibility Criteria
You may qualify if:
- Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.
- The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.
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)
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital Luwan Branch
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
March 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