Carcinomas/NeoplasmsNCT02104076
Evolution® Biliary Stent System-Fully Covered
A study testing Evolution® Biliary Stent-Fully Covered in people with Carcinomas/Neoplasms, run by Cook Group Incorporated at 12 sites in 4 countries.
Trial summary
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinomas/Neoplasms
- What is being tested?
- Evolution® Biliary Stent-Fully Covered
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2014to 4 Jan 2017
- 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
- Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent
Who cannot join
- < 18 years of age
- Unwilling or unable to sign and date the informed consent
- Unwilling or unable to comply with the follow-up schedule
- Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
- Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
- Endoscopic procedures are contraindicated
Show all 17Show fewer
- Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
- Presence of a metal biliary stent
- Presence of an esophageal or duodenal stent
- Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
- Coagulopathy
- Diffuse intrahepatic metastases that involves > 10 % of the liver
- Life expectancy of < 3 months
- Pregnant
- Active alcohol or substance abuse issue
- Jaundice secondary to a cause other than biliary duct obstruction
- Additional endoscopic restrictions as specified in the Clinical Investigation Plan
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States7 sites
University of Colorado Hospital
Aurora, Colorado, 80045
University of Virginia Health System
Charlottesville, Virginia, 22908-0908
Indiana University Hospital
Indianapolis, Indiana, 46202
Borland-Groover Clinic
Jacksonville, Florida, 32256
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Moffitt Cancer Center
Tampa, Florida, 33612
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Canada2 sites
Centre Hospitalier de 1'Université
Montreal, Quebec, H2W 1T8
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
France2 sites
Hôpital Edouard Herriot
Lyon, 69437
Hôpital L'Archet 2
Nice, 23079
About this study
Official title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
- Conditions
- Carcinomas/Neoplasms
- Being tested
- Evolution® Biliary Stent-Fully Covered
- Keywords
- Bile Duct Obstructions, Biliary Stases, Biliary Tract, Stents
- Medical subject headings
- Carcinoma, Neoplasms, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolution® Biliary Stent-Fully CoveredDevice
Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP
| Study group | Role | What they receive |
|---|---|---|
| Evolution® Biliary Stent-Fully Covered | Experimental | Not described Receives: Device: Evolution® Biliary Stent-Fully Covered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
Measured: 6 months
Total Serum Bilirubin ≤ 3.0 mg/dL
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomas/NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raj Shah, M.D., Principal investigator, University of Colorado, DenverMarco Bruno, M.D., Principal investigator, Erasmus Medish Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104076
- Sponsor's protocol ID
- 10-014
- Status last verified
- Jun 2017
- First submitted
- 2 Apr 2014
- Last updated
- 5 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
- ClinicalTrials.gov ID
- NCT02104076
- Acronym / sponsor ID
- 10-014
- Conditions
- Carcinomas/Neoplasms
- Keywords
- Bile Duct Obstructions, Biliary Stases, Biliary Tract, Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 4 Apr 2014 (estimated)
- 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 Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolution® Biliary Stent-Fully Covered | Experimental | Device: Evolution® Biliary Stent-Fully Covered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent
Key exclusion criteria (17 listed)
- < 18 years of age
- Unwilling or unable to sign and date the informed consent
- Unwilling or unable to comply with the follow-up schedule
- Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
- Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
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® Biliary Stent-Fully CoveredImplantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP | Device | Evolution® Biliary Stent-Fully Covered |
Primary outcome
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
Time frame: 6 months
Total Serum Bilirubin ≤ 3.0 mg/dL
Time frame: 1 month
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 5 Jul 2017.
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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.
Raj Shah, M.D. principal investigator
University of Colorado, Denver
Marco Bruno, M.D. principal investigator
Erasmus Medish Centrum
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evolution® Biliary Stent-Fully Covered in people with Carcinomas/Neoplasms, run by Cook Group Incorporated at 12 sites in 4 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 1 inclusion and 17 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, France, Netherlands. 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?
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention (time frame: 6 months). 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 5 Jul 2017.