Airway DiseaseNCT03890523
Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
A study testing Airway stent implantation in people with Airway Disease and Fistula Bronchial, run by Ruijin Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Disease, Fistula Bronchial, Fistula, Gastric
- What is being tested?
- Airway stent implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe infection
- coagulation disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality
Aiwu Mao, MD
- Recruiting
Ruijin Hospital Luwan Branch
Shanghai
Ju Gong
About this study
Official title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
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.
- Conditions
- Airway Disease, Fistula Bronchial, Fistula, Gastric
- Being tested
- Airway stent implantation
- Keywords
- 3D printed, airway stent, carina, distal bronchi
- Medical subject headings
- Bronchial Fistula, Gastric Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway stent implantationProcedure or surgery
Also called Stent removal
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.
| Study group | Role | What they receive |
|---|---|---|
| Segmented Airway Stent for Gastro-Respiratory fistula | Experimental | Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula. Receives: Procedure: Airway stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of symptoms
Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
Measured: 1 month
Heal of fistula
The heal of fistula confirmed by gastroscopy, bronchoscopy and CT
Measured: 3 months
Secondary outcomes (2)
Number of participants with adverse events that are related to stent implantation
Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2017
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch
- Responsible party
- Principal investigator, Zhongmin Wang, Ruijin Hospital
- Investigators
- Zhongmin Wang, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890523
- Sponsor's protocol ID
- airwaystentfistula
- Status last verified
- Feb 2020
- First submitted
- 19 Mar 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
- ClinicalTrials.gov ID
- NCT03890523
- Acronym / sponsor ID
- airwaystentfistula
- Conditions
- Airway Disease, Fistula Bronchial, Fistula, Gastric
- Keywords
- 3D printed, airway stent, carina, distal bronchi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital, Ruijin Hospital Luwan Branch
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Segmented Airway Stent for Gastro-Respiratory fistula | Experimental | Procedure: Airway stent implantationSegmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe infection
- coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway stent implantationAlso: Stent removalThe 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. | Procedure or surgery | Segmented Airway Stent for Gastro-Respiratory fistula |
Primary outcome
Relief of symptoms
Time frame: 1 month
Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
Heal of fistula
Time frame: 3 months
The heal of fistula confirmed by gastroscopy, bronchoscopy and CT
2 secondary outcomes
Number of participants with adverse events that are related to stent implantation
Time frame: 6 months
Stent patency time
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongmin Wang, MD principal investigator
Ruijin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway stent implantation in people with Airway Disease and Fistula Bronchial, run by Ruijin Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongmin Wang, MD (0086-13901848333, wzm0722@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of symptoms (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.