Malignant Obstruction of the Common Bile DuctNCT00448006
Clinical Feasibility Study of Allium's Biliary Stent
A study testing Allium Biliary Stent in people with Malignant Obstruction of the Common Bile Duct, run by Allium, Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Obstruction of the Common Bile Duct
- What is being tested?
- Allium Biliary Stent
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Aug 2009
- 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
- Patient is 18 years or older
- Patient has malignant obstructive jaundice
- Patient is unfit for surgery
- Patient is capable of giving informed consent
- Patient is willing to comply with study requirements
Who cannot join
- Patient has a benign biliary duct obstruction
- Patient cannot tolerate any form of antibiotic treatment
- Patient is currently receiving anticoagulation therapy
- Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From "Malignant Biliary Duct Obstruction" (Endoscopic Insertion)
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.
Read the detailed description
Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.
- Being tested
- Allium Biliary Stent
- Keywords
- common, bile, duct, biliary, malignant, obstruction, stent
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium Biliary StentDevice
device
allium biliary stentDevice
Also called self expandable stent
allium biliary stent
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.
Measured: up to 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startApr 2008 (estimated)
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Obstruction of the Common Bile DuctStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allium, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Bar-Meir, M.D., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448006
- Sponsor's protocol ID
- BIS-CL-001
- Status last verified
- Apr 2008
- First submitted
- 14 Mar 2007
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From "Malignant Biliary Duct Obstruction" (Endoscopic Insertion)
- ClinicalTrials.gov ID
- NCT00448006
- Acronym / sponsor ID
- BIS-CL-001
- Keywords
- common, bile, duct, biliary, malignant, obstruction, stent
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allium, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008 (estimated)
- Primary completion
- Aug 2009
- First posted
- 15 Mar 2007 (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 purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.
Detailed description
Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 18 years or older
- Patient has malignant obstructive jaundice
- Patient is unfit for surgery
- Patient is capable of giving informed consent
- Patient is willing to comply with study requirements
Key exclusion criteria (4 listed)
- Patient has a benign biliary duct obstruction
- Patient cannot tolerate any form of antibiotic treatment
- Patient is currently receiving anticoagulation therapy
- Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)
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 |
|---|---|---|
| Allium Biliary Stentdevice | Device | – |
| allium biliary stentAlso: self expandable stentallium biliary stent | Device | – |
Primary outcome
Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.
Time frame: up to 12 months follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- The Chaim Sheba Medical Center at Tel HashomerLink provided by the sponsor.
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.
Simon Bar-Meir, M.D. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allium Biliary Stent in people with Malignant Obstruction of the Common Bile Duct, run by Allium, Ltd. at 1 site in Israel.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion. (time frame: up to 12 months follow up). 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 10 Jul 2018.