Pulmonary Disease, Chronic ObstructiveNCT03111888
Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
A study testing Silicone Stent Airway Implant in people with Pulmonary Disease, Chronic Obstructive and Emphysema, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. The first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Emphysema
- What is being tested?
- Silicone Stent Airway Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Patients must be at least 18 years of age
- Patients must be able to undergo routine non-contrast CT scans of the chest
- Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
- The patients must have at least an expected 6 month survival.
- Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
- Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design
- Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS
Who cannot join
- Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
- Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES)or 6 weeks following bare metal coronary stent)
- Unstable cardiac disease
- Allergy to silicone
- Stenting to manage vascular compression syndromes.
- Multi-drug resistant bacterial or fungal chronic infections
- Emergent/urgent clinically indicated stent.
- Chronic/permanent mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Feasibility Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
The goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. The first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. The end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.
Read the detailed description
Subjects will be selected from physician investigator's clinical practice where patients have had failure of current stenting procedures to achieve an adequate clinical outcome. A routine CT scan of the chest is required on all individuals going through the procedure for stent placement (rigid bronchoscopy). The physician investigator will use this CT scan to measure and build a patient-specific stent or modify existing stents to fit the specific need.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Emphysema
- Being tested
- Silicone Stent Airway Implant
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Stent Airway ImplantDevice
The Patient-Specific Tracheobronchial Stent is a silicone stent indicated for use in adults that have stenosis of the airway. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally build the stent to his/her desired dimensions. According to the physician's design, a patient-specific stent can be manufactured using rapid prototyping technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific Tracheobronchial Stent | Experimental | Observe and document the ability of a patient-specific tracheobronchial stent to improve a patient's quality of life and symptoms associated with airway stenosis. Receives: Device: Silicone Stent Airway Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe the outcomes associated with patient-specific airway implants.
Measure Quality of Life Index through Baseline Dyspnea Index, a validated survey tool
Measured: Up to 90 days following treatment
Observe the outcomes associated with patient-specific airway implants.
Measure Quality of Life Index through Transitional Dyspnea Index, a validated survey tool
Measured: Up to 90 days following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Oct 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Custom Orthopaedic Solutions
- Responsible party
- Sponsor
- Investigators
- Thomas R Gildea, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111888
- Sponsor's protocol ID
- gildea0217
- Status last verified
- Mar 2018
- First submitted
- 4 Apr 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Feasibility Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
- ClinicalTrials.gov ID
- NCT03111888
- Acronym / sponsor ID
- gildea0217
- Conditions
- Pulmonary Disease, Chronic Obstructive, Emphysema
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Custom Orthopaedic Solutions
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 13 Apr 2017 (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.
The goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. The first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. The end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.
Detailed description
Subjects will be selected from physician investigator's clinical practice where patients have had failure of current stenting procedures to achieve an adequate clinical outcome. A routine CT scan of the chest is required on all individuals going through the procedure for stent placement (rigid bronchoscopy). The physician investigator will use this CT scan to measure and build a patient-specific stent or modify existing stents to fit the specific need.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific Tracheobronchial Stent | Experimental | Device: Silicone Stent Airway ImplantObserve and document the ability of a patient-specific tracheobronchial stent to improve a patient's quality of life and symptoms associated with airway stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understand and voluntarily sign an informed consent form.
- Patients must be at least 18 years of age
- Patients must be able to undergo routine non-contrast CT scans of the chest
- Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
- The patients must have at least an expected 6 month survival.
Key exclusion criteria (8 listed)
- Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
- Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES)or 6 weeks following bare metal coronary stent)
- Unstable cardiac disease
- Allergy to silicone
- Stenting to manage vascular compression syndromes.
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 |
|---|---|---|
| Silicone Stent Airway ImplantThe Patient-Specific Tracheobronchial Stent is a silicone stent indicated for use in adults that have stenosis of the airway. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally build the stent to his/her desired dimensions. According to the physician's design, a patient-specific stent can be manufactured using rapid prototyping technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope. | Device | Patient-Specific Tracheobronchial Stent |
Primary outcome
Observe the outcomes associated with patient-specific airway implants.
Time frame: Up to 90 days following treatment
Measure Quality of Life Index through Baseline Dyspnea Index, a validated survey tool
Observe the outcomes associated with patient-specific airway implants.
Time frame: Up to 90 days following treatment
Measure Quality of Life Index through Transitional Dyspnea Index, a validated survey tool
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- 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.
Thomas R Gildea, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Stent Airway Implant in people with Pulmonary Disease, Chronic Obstructive and Emphysema, run by The Cleveland Clinic at 1 site in United States.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the outcomes associated with patient-specific airway implants. (time frame: Up to 90 days following treatment). 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 8 Mar 2018.