Esophageal DiseasesNCT05182255
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
An observational study of Esophageal Diseases, run by Cook Research Incorporated at 5 sites in 3 countries.
Trial summary
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 28 Apr 2022to 8 Dec 2023
- Phase
- Observational
- 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
Study population: All consecutive patients who underwent stent placement with a study device between Jan 1,2018 thru Dec 31, 2020
Who may be able to join
- 1: Patient has had at least one of the following stents implanted between 1st January 2018 and 31st December 2020:
- Evolution® Esophageal Stent System-Partially Covered
- Evolution® Esophageal Stent System-Fully Covered
- Evolution® Esophageal Stent System-Fully Covered
Who cannot join
- 1: Deceased retrospective patient who has set post-mortem instruction against processing of his/her health data
- 2. Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to sign not willing to sign an Informed consent, if it is required by the local EC committee. There may be local exemptions where consent is not a requirement or non-objection letters may replace informed consent processes.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Klinikum Altenburg
Altenburg, 04600
Universitatsklinikum Augsburg
Augsburg, 86156
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
About this study
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
Read the detailed description
Cook Evolution® Esophageal Stent Post-Market Data Collection Study
A retrospective observational, multi-center, chart review study will be performed. Data specific to Cook Evolution® Esophageal Stent placement procedures from all consecutive patients who underwent stent placement with any of the stents at the participating sites between 1st January 2015 and 31st December 2020 (index period) will be collected. Research on the commercially available Cook Evolution® Esophageal Stents is being conducted to comply with the new medical device regulation, EU 2017/745, to assess the device for its continued safety and performance. To do this, Cook Research Incorporated is working with participating hospitals to collect pseudonymized (coded) personal health data. This study is in the interest of public health; to learn more about the necessary data processing, please visit the webpage below.
https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice.pdf
Spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice_ESP.pdf
- Conditions
- Esophageal Diseases
- Being tested
- Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
- Keywords
- Unresectable esophageal malignancies, Benign strictures, Tracheoesophageal fistulas, Esophageal stents
- Medical subject headings
- Esophageal Diseases, Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolution® Esophageal Stent Systems, Europe: Fully and Partially CoveredDevice
To aid in maintaining patency of the esophagus in cases of obstruction of the esophagus caused by an esophageal disease and to seal tracheoesophageal fistula.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Stent Systems | Freedom from endoscopic re-intervention due to recurrence of dysphagia Receives: Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically relevant device migration
Clinically relevant device migration is defined as stent migration requiring replacement of the stent due to degree of migration as well as clinical symptoms (i.e. an inability of the stent to perform its intended function).
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 posted10 Jan 2022
- Study start28 Apr 2022
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182255
- Sponsor's protocol ID
- MDR-2054
- Status last verified
- Jul 2024
- First submitted
- 16 Dec 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
- ClinicalTrials.gov ID
- NCT05182255
- Acronym / sponsor ID
- MDR-2054
- Conditions
- Esophageal Diseases
- Keywords
- Unresectable esophageal malignancies, Benign strictures, Tracheoesophageal fistulas, Esophageal stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 10 Jan 2022 (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 aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
Detailed description
Cook Evolution® Esophageal Stent Post-Market Data Collection Study
A retrospective observational, multi-center, chart review study will be performed. Data specific to Cook Evolution® Esophageal Stent placement procedures from all consecutive patients who underwent stent placement with any of the stents at the participating sites between 1st January 2015 and 31st December 2020 (index period) will be collected. Research on the commercially available Cook Evolution® Esophageal Stents is being conducted to comply with the new medical device regulation, EU 2017/745, to assess the device for its continued safety and performance. To do this, Cook Research Incorporated is working with participating hospitals to collect pseudonymized (coded) personal health data. This study is in the interest of public health; to learn more about the necessary data processing, please visit the webpage below.
https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice.pdf
Spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice_ESP.pdf
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal Stent Systems | – | Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially CoveredFreedom from endoscopic re-intervention due to recurrence of dysphagia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who underwent stent placement with a study device between Jan 1,2018 thru Dec 31, 2020
Key inclusion criteria (4 listed)
- 1: Patient has had at least one of the following stents implanted between 1st January 2018 and 31st December 2020:
- Evolution® Esophageal Stent System-Partially Covered
- Evolution® Esophageal Stent System-Fully Covered
- Evolution® Esophageal Stent System-Fully Covered
Key exclusion criteria (2 listed)
- 1: Deceased retrospective patient who has set post-mortem instruction against processing of his/her health data
- 2. Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to sign not willing to sign an Informed consent, if it is required by the local EC committee. There may be local exemptions where consent is not a requirement or non-objection letters may replace informed consent processes.
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 |
|---|---|---|
| Evolution® Esophageal Stent Systems, Europe: Fully and Partially CoveredTo aid in maintaining patency of the esophagus in cases of obstruction of the esophagus caused by an esophageal disease and to seal tracheoesophageal fistula. | Device | Esophageal Stent Systems |
Primary outcome
Number of participants with clinically relevant device migration
Time frame: 6 months
Clinically relevant device migration is defined as stent migration requiring replacement of the stent due to degree of migration as well as clinical symptoms (i.e. an inability of the stent to perform its intended function).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Diseases, run by Cook Research Incorporated at 5 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Spain, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with clinically relevant device migration (time frame: 6 months). 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 12 Feb 2025.