Biliary Strictures Caused by Malignant NeoplasmsNCT00713427
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
A study testing WallFlex™ Biliary Partially-Covered Stent in people with Biliary Strictures Caused by Malignant Neoplasms, run by Boston Scientific Corporation at 6 sites in 6 countries.
Trial summary
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially 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
- Biliary Strictures Caused by Malignant Neoplasms
- What is being tested?
- WallFlex™ Biliary Partially-Covered Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jul 2007to May 2008
- Phase
- Interventional
- 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 years or older
- Inoperable extrahepatic biliary obstruction by any malignant process
- Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Who cannot join
- Participation in another invesitgational study within 90 days prior to date of patient consent.
- Strictures that cannot be dialated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of any esophageal or duodenal stent
- Patients for whom endoscopic procedures are contraindicated
- Patients with known senesitivity to any components of the stent or delivery system
- Patients with active hepatitis
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Netherlands1 site
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, AZ, 1105
About this study
Official title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
- Being tested
- WallFlex™ Biliary Partially-Covered Stent
- Keywords
- Biliary, Strictures, Malignant, Neoplasm, Palliation
- Medical subject headings
- Constriction, Pathologic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary Partially-Covered StentDevice
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.
| Study group | Role | What they receive |
|---|---|---|
| WallFlex Stent | Other | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. Receives: Device: WallFlex™ Biliary Partially-Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Absence of Recurrent Biliary Obstruction
Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.
Measured: Up to 6 months post treatment or prior to death, whichever came first
Secondary outcomes (6)
Number of Adverse Events Related to the Device and/or Procedure
Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.
Measured: From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)
Number of Participants With Technical Stent Placement Success
Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture
Measured: Initial stent placement procedure
Number of Participants With Occurrence of Re-intervention
A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture.
Measured: Up to 6 months post-initial study treatment
Change in Biliary Obstruction Symptoms
Incidence of symptoms of biliary obstruction
Measured: up to 6 months post-initial study treatment
Time to Recurrent Biliary Obstruction
Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded.
Measured: Up to 6 months
Change in Bilirubin
Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.
Measured: 1 month following stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 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 Biliary Strictures Caused by Malignant NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Walsh, M.D., Study director, Boston Scientific CorporationGuido Costamagna, M.D., Principal investigator, Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713427
- Sponsor's protocol ID
- ENDO-WALLFLEX-BIL-PALL-002
- Other IDs
- E7020
- Status last verified
- Aug 2009
- First submitted
- 9 Jul 2008
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. 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 Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT00713427
- Acronym / sponsor ID
- ENDO-WALLFLEX-BIL-PALL-002
- Keywords
- Biliary, Strictures, Malignant, Neoplasm, Palliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WallFlex Stent | Other | Device: WallFlex™ Biliary Partially-Covered StentAll patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. |
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 years or older
- Inoperable extrahepatic biliary obstruction by any malignant process
- Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Participation in another invesitgational study within 90 days prior to date of patient consent.
- Strictures that cannot be dialated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of any esophageal or duodenal stent
- Patients for whom endoscopic procedures are contraindicated
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 Partially-Covered StentImplantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. | Device | WallFlex Stent |
Primary outcome
Number of Participants With Absence of Recurrent Biliary Obstruction
Time frame: Up to 6 months post treatment or prior to death, whichever came first
Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.
6 secondary outcomes
Number of Adverse Events Related to the Device and/or Procedure
Time frame: From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)
Number of Participants With Technical Stent Placement Success
Time frame: Initial stent placement procedure
Number of Participants With Occurrence of Re-intervention
Time frame: Up to 6 months post-initial study treatment
Change in Biliary Obstruction Symptoms
Time frame: up to 6 months post-initial study treatment
Time to Recurrent Biliary Obstruction
Time frame: Up to 6 months
Change in Bilirubin
Time frame: 1 month following stent placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Walsh, M.D. study director
Boston Scientific Corporation
Guido Costamagna, M.D. principal investigator
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex™ Biliary Partially-Covered Stent in people with Biliary Strictures Caused by Malignant Neoplasms, run by Boston Scientific Corporation at 6 sites in 6 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 7 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, France, Germany, India, Italy and 1 more country. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2021). 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?
Number of Participants With Absence of Recurrent Biliary Obstruction (time frame: Up to 6 months post treatment or prior to death, whichever came first). 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 30 Jul 2021.