Stricture; TracheaNCT03890575
Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi
A study testing Airway stent implantation in people with Stricture; Trachea and Malignant Neoplasm, run by Ruijin Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stricture; Trachea, Malignant Neoplasm
- 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 Apr 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 malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.
Who cannot join
- Severe infection
- Coagulation disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital Luwan Branch
Shanghai
Ju Gong
- Recruiting
Shanghai Tongren Hospital
Shanghai
Aiwu Mao
About this study
Official title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
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.
- Conditions
- Stricture; Trachea, Malignant Neoplasm
- Being tested
- Airway stent implantation
- Keywords
- 3D printed, airway stent, carina, distal bronchi
- Medical subject headings
- Tracheal Stenosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway stent implantationProcedure or surgery
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
| Study group | Role | What they receive |
|---|---|---|
| Airway Stent for Malignant Stricture | Experimental | Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing. Receives: Procedure: Airway stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Dyspnea using Hugh-Jones classication as criteria
Hugh-Jones classication: dyspnea scale that includes 5 categories.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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: 2 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 Apr 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 Stricture; TracheaStudies 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
- NCT03890575
- Sponsor's protocol ID
- malignantairwaystent
- 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 Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
- ClinicalTrials.gov ID
- NCT03890575
- Acronym / sponsor ID
- malignantairwaystent
- Conditions
- Stricture; Trachea, Malignant Neoplasm
- 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 Apr 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Stent for Malignant Stricture | Experimental | Procedure: Airway stent implantationPatients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.
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 implantationThe airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina. | Procedure or surgery | Airway Stent for Malignant Stricture |
Primary outcome
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.
1 secondary outcome
Number of participants with adverse events that are related to stent implantation
Time frame: 2 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
Related trials for Stricture; Trachea
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingPhase 3
Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
Idiopathic Subglottic Stenosis
Recruiting
Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
Tracheal Stenosis
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Not yet recruitingObservational study
Voice Quality Analysis of Patients With Laryngotracheal Stenosis
Idiopathic Subglottic Tracheal Stenosis
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 Stricture; Trachea and Malignant Neoplasm, 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 1 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?
Improvement in Dyspnea using Hugh-Jones classication as criteria (time frame: 3 days). The study lists 3 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.