NCT01899976

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2017

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

July 8, 2013

Last Update Submit

April 5, 2022

Conditions

Biliary Tract Cancer

Keywords

covered biliary stentX-Suit NIR Covered Biliary Stentmalignant strictures in biliary tree

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months follow up or prior to death, whichever comes first

Secondary Outcomes (1)

  • total number of adverse events

    6 months

Study Arms (1)

X-Suit NIR Covered Biliary Stent

OTHER

Stent implantation in the biliary tree

Device: X-Suit NIR Covered Biliary Stent

Interventions

X-Suit NIR Covered Biliary StentDEVICE
X-Suit NIR Covered Biliary Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \. Participation in an Investigational Study within 90 days prior to date of subject consent.
  • \. 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.
  • \. 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.
  • \. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system.
  • \. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
  • \. Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).
  • \. Subjects known to be pregnant.
  • \. Strictures that cannot be passed by the guide wire or the delivery system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital Erasme Brussels (ULB)

Brussels, 1070, Belgium

Location

Hillel Yafeh Medical Center

Hadera, 38100, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Haddasah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

University Medical Center Utrecht

Utrecht, Heidelberglaan, 100, 3584 CX, Netherlands

Location

Academic Medical Center (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Peter D Siersema, Prof.

    University Medical Center Utrecht, Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 16, 2013

Study Start

August 1, 2013

Primary Completion

November 13, 2017

Study Completion

November 13, 2017

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

IL(6)NL(2)BE(1)