Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction
July 18, 2018 updated by: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
Comparison of Flare Type Self-expandable Metal Stent With Conventional D-type Self-expandable Metal Stent for Malignant Colorectal Obstruction
This study compares flare type self-expandable metal stent with conventional D-type self-expandable metal stent for malignant colorectal obstruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Daegu, Korea, Republic of, 41944
- Kyungpook National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Malignant colorectal obstruction confirmed by radiologic study
Exclusion Criteria:
- Bowel perforation
- Multiple obstruction
- Benign obstruction
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Flare type stent
Flare type stent (Taewoong medical) has a wide diameter at proximal end to prevent stent migration.
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Flare type has a wide diameter at proximal portion to prevent stent migration.
|
|
Active Comparator: Conventional D-type stent
Conventional D-type (Taewoong medical) stent has a same diameter at both ends.
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This stent is an original full covered stent to treat malignant colorectal obstruction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical success rate
Time Frame: 48 hours
|
Colon obstruction is relieved.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
July 18, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 18, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNUH13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.