Cholestasis, ExtrahepaticPhase 3NCT00433771
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
A Phase 3 study testing WallFlex™ Biliary Fully Covered Metal Stent placement in people with Cholestasis, Extrahepatic, run by Boston Scientific Corporation at 10 sites in United States.
Trial summary
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholestasis, Extrahepatic
- What is being tested?
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2007to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Clinical symptoms of biliary obstruction
- Inoperable extrahepatic biliary obstruction by any malignant process
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Participation in an Investigational Study within 90 days prior to date of patient consent
- Strictures that cannot be dilated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of a metal biliary stent
- Presence of any esophageal or duodenal stent
- Patients for whom endoscopic procedures are contraindicated
Show all 9Show fewer
- Patients with known sensitivity to any components of the stent or delivery system
- Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
- Patients with an anticipated life expectancy of < 3 months
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Univ. of Colorado Health Sciences
Aurora, Colorado, 80010
Univ. of VA Medical Center
Charlottesville, Virginia, 800708
Duke University Med Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
California Pacific Medical Center
San Francisco, California, 94115
Virginia Mason Seattle Main Clinic
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Conditions
- Cholestasis, Extrahepatic
- Being tested
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Keywords
- Malignant, Cholestasis, Extrahepatic, Biliary obstruction
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary Fully Covered Metal Stent placementDevice
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.
| Study group | Role | What they receive |
|---|---|---|
| WallFlex Biliary Fully Covered stent | Experimental | Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent Receives: Device: WallFlex™ Biliary Fully Covered Metal Stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Clinical Palliation of the Biliary Obstruction
Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.
Measured: 6 months
Secondary outcomes (12)
Technical Success
Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.
Measured: At treatment
Ability to Successfully Remove a Stent Upon Removal Attempt
The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
Measured: 6 months
Re-interventions
Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.
Measured: Until 6 months or death
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.
Measured: 1 Month
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.
Measured: 3 months
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.
Measured: 6 months
Bilirubin Level Reduction
Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.
Measured: 1 month
Stent Patency at 1 Month
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.
Measured: 1 month
Stent Patency at 3 Months
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).
Measured: 3 Months
Stent Patency at 6 Months
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).
Measured: 6 Months
Time to Stent Occlusion
Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Measured: Until 6 Months or death
Number of Device-Related Adverse Events
Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.
Measured: Until 6 months or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cholestasis, ExtrahepaticStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bret Petersen, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433771
- Sponsor's protocol ID
- ENDO-WALLFLEX-BIL-PALL-001U
- Other IDs
- E7009
- Status last verified
- Jun 2010
- First submitted
- 8 Feb 2007
- Last updated
- 29 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT00433771
- Acronym / sponsor ID
- ENDO-WALLFLEX-BIL-PALL-001U
- Conditions
- Cholestasis, Extrahepatic
- Keywords
- Malignant, Cholestasis, Extrahepatic, Biliary obstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Posted 9 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WallFlex Biliary Fully Covered stent | Experimental | Device: WallFlex™ Biliary Fully Covered Metal Stent placementSingle arm, biliary stenting, using WallFlex Biliary Fully Covered stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Clinical symptoms of biliary obstruction
- Inoperable extrahepatic biliary obstruction by any malignant process
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Participation in an Investigational Study within 90 days prior to date of patient consent
- Strictures that cannot be dilated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of a metal biliary stent
- Presence of any esophageal or duodenal stent
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 |
|---|---|---|
| WallFlex™ Biliary Fully Covered Metal Stent placementImplantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent. | Device | WallFlex Biliary Fully Covered stent |
Primary outcome
Adequate Clinical Palliation of the Biliary Obstruction
Time frame: 6 months
Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.
12 secondary outcomes
Technical Success
Time frame: At treatment
Ability to Successfully Remove a Stent Upon Removal Attempt
Time frame: 6 months
Re-interventions
Time frame: Until 6 months or death
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
Time frame: 1 Month
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Time frame: 3 months
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Time frame: 6 months
Bilirubin Level Reduction
Time frame: 1 month
Stent Patency at 1 Month
Time frame: 1 month
Stent Patency at 3 Months
Time frame: 3 Months
Stent Patency at 6 Months
Time frame: 6 Months
Time to Stent Occlusion
Time frame: Until 6 Months or death
Number of Device-Related Adverse Events
Time frame: Until 6 months or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Bret Petersen, MD principal investigator
Mayo Clinic, Rochester, MN
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WallFlex™ Biliary Fully Covered Metal Stent placement in people with Cholestasis, Extrahepatic, run by Boston Scientific Corporation at 10 sites 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 4 inclusion and 9 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 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adequate Clinical Palliation of the Biliary Obstruction (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 29 Jun 2010; AzTrials last refreshed its copy on 2 Nov 2026.