Biliary Tract NeoplasmsNCT01962168
Evolution® Biliary Stent System Clinical Study
An observational study of Biliary Tract Neoplasms and Neoplasms, run by Cook Group Incorporated at 9 sites in 2 countries.
Trial summary
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases
- What is being tested?
- Evolution® Biliary Stent - Uncovered
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2013to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates for biliary stent placement based on institutional guidelines and product IFU.
Who may be able to join
- Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.
Who cannot join
- Patient is less than 18 years of age.
- Patient is unable or unwilling to provide written informed consent.
- Patient is unable or unwilling to comply with the follow-up schedule.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Northwest Community Hospital
Arlington Heights, Illinois, 60005
The Pancreas and Biliary Center of South Florida
Boca Raton, Florida, 33486
Borland-Groover Clinic
Jacksonville, Florida, 32256
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Florida Hospital
Orlando, Florida, 32803
SUNY at Stony Brook Hospital
Stony Brook, New York, 11794
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Canada1 site
Centre Hospitalier de l' Universite de Montreal (CHUM)
Montreal, Quebec, H2X 3J4
About this study
Official title: Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
- Being tested
- Evolution® Biliary Stent - Uncovered
- Keywords
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
- Medical subject headings
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolution® Biliary Stent - UncoveredDevice
Commercially available device
| Study group | Role | What they receive |
|---|---|---|
| Evolution® Biliary Stent - Uncovered | Not described Receives: Device: Evolution® Biliary Stent - Uncovered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
Measured: 6 months
Secondary outcomes (3)
Technical success
Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.
Measured: Immediately following completion of the stent placement procedure
Incidence of device-related adverse events
Measured: 6 months
Ease of use
Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.
Measured: Immediately following completion of the stent placement procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Lawrence, Principal investigator, Summerville GI & Advanced Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962168
- Sponsor's protocol ID
- 12-009
- Status last verified
- Apr 2015
- First submitted
- 9 Oct 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
Publications
Lawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9.
PubMed 32522161
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
- ClinicalTrials.gov ID
- NCT01962168
- Acronym / sponsor ID
- 12-009
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
- Keywords
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Oct 2013 (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 Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolution® Biliary Stent - Uncovered | – | Device: Evolution® Biliary Stent - Uncovered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates for biliary stent placement based on institutional guidelines and product IFU.
Key inclusion criteria (1 listed)
- Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.
Key exclusion criteria (3 listed)
- Patient is less than 18 years of age.
- Patient is unable or unwilling to provide written informed consent.
- Patient is unable or unwilling to comply with the follow-up schedule.
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 - UncoveredCommercially available device | Device | Evolution® Biliary Stent - Uncovered |
Primary outcome
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
Time frame: 6 months
3 secondary outcomes
Technical success
Time frame: Immediately following completion of the stent placement procedure
Incidence of device-related adverse events
Time frame: 6 months
Ease of use
Time frame: Immediately following completion of the stent placement procedure
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 8 Apr 2015.
- Derived from this study: PubMed 32522161Lawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9.
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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.
Christopher Lawrence principal investigator
Summerville GI & Advanced Endoscopy
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Neoplasms and Neoplasms, run by Cook Group Incorporated at 9 sites in 2 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 3 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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?
Freedom from symptomatic recurrent biliary obstruction requiring reintervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962168, which also lists 1 linked publication.
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 Apr 2015.