Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01962168
Other study ID # 12-009
Secondary ID
Status Completed
Phase N/A
First received October 9, 2013
Last updated April 7, 2015
Start date December 2013
Est. completion date March 2015

Study information

Verified date April 2015
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.

Exclusion Criteria:

- Patient is less than 18 years of age.

- Patient is unable or unwilling to provide written informed consent.

- Patient is unable or unwilling to comply with the follow-up schedule.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Evolution® Biliary Stent - Uncovered
Commercially available device

Locations

Country Name City State
Canada Centre Hospitalier de l' Universite de Montreal (CHUM) Montreal Quebec
United States Northwest Community Hospital Arlington Heights Illinois
United States The Pancreas and Biliary Center of South Florida Boca Raton Florida
United States Borland-Groover Clinic Jacksonville Florida
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Mobile Infirmary Medical Center Mobile Alabama
United States Florida Hospital Orlando Florida
United States SUNY at Stony Brook Hospital Stony Brook New York
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from symptomatic recurrent biliary obstruction requiring reintervention 6 months No
Secondary Technical success Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure. Immediately following completion of the stent placement procedure No
Secondary Incidence of device-related adverse events 6 months Yes
Secondary Ease of use Ease of use will be evaluated on a five point scale ranging from very easy to very difficult. Immediately following completion of the stent placement procedure No
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A