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Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Flare type stent

Conventional D-type stent

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, stent

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Malignant colorectal obstruction confirmed by radiologic study

Exclusion Criteria:

Bowel perforation
Multiple obstruction
Benign obstruction
Pregnancy

Sites / Locations

Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flare type stent

Conventional D-type stent

Arm Description

Flare type stent (Taewoong medical) has a wide diameter at proximal end to prevent stent migration.

Conventional D-type (Taewoong medical) stent has a same diameter at both ends.

Outcomes

Primary Outcome Measures

Clinical success rate

Colon obstruction is relieved.

Secondary Outcome Measures

Full Information

NCT ID

NCT03602417

First Posted

September 19, 2017

Last Updated

July 18, 2018

Sponsor

Kyungpook National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03602417

Brief Title

Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction

Official Title

Comparison of Flare Type Self-expandable Metal Stent With Conventional D-type Self-expandable Metal Stent for Malignant Colorectal Obstruction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

March 1, 2018 (Actual)

Study Completion Date

May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyungpook National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares flare type self-expandable metal stent with conventional D-type self-expandable metal stent for malignant colorectal obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

colorectal cancer, stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flare type stent

Arm Type

Experimental

Arm Description

Flare type stent (Taewoong medical) has a wide diameter at proximal end to prevent stent migration.

Arm Title

Conventional D-type stent

Arm Type

Active Comparator

Arm Description

Conventional D-type (Taewoong medical) stent has a same diameter at both ends.

Intervention Type

Device

Intervention Name(s)

Flare type stent

Intervention Description

Flare type has a wide diameter at proximal portion to prevent stent migration.

Intervention Type

Device

Intervention Name(s)

Conventional D-type stent

Intervention Description

This stent is an original full covered stent to treat malignant colorectal obstruction.

Primary Outcome Measure Information:

Title

Clinical success rate

Description

Colon obstruction is relieved.

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Malignant colorectal obstruction confirmed by radiologic study Exclusion Criteria: Bowel perforation Multiple obstruction Benign obstruction Pregnancy

Facility Information:

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction

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