Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
NCT ID: NCT01102283
Last Updated: 2013-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
80 participants
OBSERVATIONAL
2010-04-30
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stent Group
Evolution(R) Colonic Stent
Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evolution(R) Colonic Stent
Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* large bowel obstruction due to malignant strictures prior to colectomy.
Exclusion:
* central ischemia,
* any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
* suspected or impending perforation,
* intra-abdominal abscess/perforation,
* inability to pass wire guide or stent deployment system through the obstructed area,
* patients for whom endoscopic or percutaneous procedures are contraindicated,
* benign disease, and
* coagulopathy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cook Group Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kingston General Hospital
Kingston, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Odense Universitetshospital
Odense, , Denmark
Institut Paoli Calmettes
Marseille, , France
Instituto Clinico Humanitas IRCCS
Milan, , Italy
Deventer Ziekenhuis
Deventer, , Netherlands
Hospital de Basurto
Bilbao, Bilbao, Spain
Hospital Universitari de Girona
Girona, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
University College of London Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
100041
Identifier Type: OTHER
Identifier Source: secondary_id
09-022
Identifier Type: -
Identifier Source: org_study_id