Biliary Tract CancerNCT01899976
X-MAS Biliary Study With Covered Biliary Stent
A study testing X-Suit NIR Covered Biliary Stent in people with Biliary Tract Cancer, run by Medinol Ltd. at 9 sites in 3 countries.
Trial summary
The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- X-Suit NIR Covered Biliary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Aug 2013to 13 Nov 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
- Age 18 or older.
- Clinical symptoms of biliary obstruction.
- Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass >2.0cm or a severe medical illness).
- Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Insured by Social Security (applicable to subjects screened in France).
Who cannot join
- 1. Participation in an Investigational Study within 90 days prior to date of subject consent.
- 2. Perforation of any duct within the biliary tree. 3. Presence of more than one previously implanted plastic stent. 4. Previous plastic stent implantation less than 2 weeks prior to current procedure.
- 5. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.
- 8. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system.
- 10. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
- 11. Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).
Show all 9Show fewer
- 12. Subjects known to be pregnant.
- Cholangiographic exclusion criterion:
- 13. Strictures that cannot be passed by the guide wire or the delivery system.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Israel6 sites
Hillel Yafeh Medical Center
Hadera, 38100
Rambam Medical Center
Haifa, 31096
Shaare Zedek Medical Center
Jerusalem, 91031
Haddasah Medical Center
Jerusalem, 91120
Sheba Medical Center, Tel Hashomer
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Netherlands2 sites
Academic Medical Center (AMC)
Amsterdam, 1105 AZ
University Medical Center Utrecht
Utrecht, Heidelberglaan, 100, 3584 CX
About this study
Official title: A Non-Randomized, Multi-Center, Prospective, Single Arm Clinical Study of the X-SUIT NIR® Covered Biliary Metallic Stent for Palliation of Malignant Strictures in the Biliary Tree Via Endoscopic Approach
The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.
Read the detailed description
This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach.
Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process.
The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.
- Conditions
- Biliary Tract Cancer
- Being tested
- X-Suit NIR Covered Biliary Stent
- Keywords
- covered biliary stent, X-Suit NIR Covered Biliary Stent, malignant strictures in biliary tree
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Suit NIR Covered Biliary StentDevice
| Study group | Role | What they receive |
|---|---|---|
| X-Suit NIR Covered Biliary Stent | Other | Stent implantation in the biliary tree Receives: Device: X-Suit NIR Covered Biliary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL- outcome
Measured: 6 months follow up or prior to death, whichever comes first
Secondary outcomes (1)
total number of adverse events
total number of adverse events (anticipated and unanticipated)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2013
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter D Siersema, Prof., Principal investigator, University Medical Center Utrecht, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899976
- Sponsor's protocol ID
- Protocol Number BI-03-01
- Status last verified
- Apr 2022
- First submitted
- 8 Jul 2013
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Multi-Center, Prospective, Single Arm Clinical Study of the X-SUIT NIR® Covered Biliary Metallic Stent for Palliation of Malignant Strictures in the Biliary Tree Via Endoscopic Approach
- ClinicalTrials.gov ID
- NCT01899976
- Acronym / sponsor ID
- Protocol Number BI-03-01
- Conditions
- Biliary Tract Cancer
- Keywords
- covered biliary stent, X-Suit NIR Covered Biliary Stent, malignant strictures in biliary tree
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 16 Jul 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 purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.
Detailed description
This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach.
Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process.
The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-Suit NIR Covered Biliary Stent | Other | Device: X-Suit NIR Covered Biliary StentStent implantation in the biliary tree |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older.
- Clinical symptoms of biliary obstruction.
- Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass >2.0cm or a severe medical illness).
- Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Insured by Social Security (applicable to subjects screened in France).
Key exclusion criteria (9 listed)
- 1. Participation in an Investigational Study within 90 days prior to date of subject consent.
- 2. Perforation of any duct within the biliary tree. 3. Presence of more than one previously implanted plastic stent. 4. Previous plastic stent implantation less than 2 weeks prior to current procedure.
- 5. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.
- 8. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system.
- 10. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
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 |
|---|---|---|
| X-Suit NIR Covered Biliary Stent | Device | X-Suit NIR Covered Biliary Stent |
Primary outcome
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL
Time frame: 6 months follow up or prior to death, whichever comes first
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL- outcome
1 secondary outcome
total number of adverse events
Time frame: 6 months
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 13 Apr 2022.
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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.
Peter D Siersema, Prof. principal investigator
University Medical Center Utrecht, Netherlands
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-Suit NIR Covered Biliary Stent in people with Biliary Tract Cancer, run by Medinol Ltd. at 9 sites in 3 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 5 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 13 Apr 2022. 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 Israel, Netherlands, Belgium. 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?
Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL (time frame: 6 months follow up or prior to death, whichever comes 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 13 Apr 2022.