NCT03602417

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

September 19, 2017

Last Update Submit

July 18, 2018

Conditions

Colorectal Cancer

Keywords

colorectal cancerstent

Outcome Measures

Primary Outcomes (1)

  • Clinical success rate

    Colon obstruction is relieved.

    48 hours

Study Arms (2)

Flare type stent

EXPERIMENTAL

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

Device: Flare type stent

Conventional D-type stent

ACTIVE COMPARATOR

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

Device: Conventional D-type stent

Interventions

Flare type stentDEVICE

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

Flare type stent
Conventional D-type stentDEVICE

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

Conventional D-type stent

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant colorectal obstruction confirmed by radiologic study

You may not qualify if:

  • Bowel perforation
  • Multiple obstruction
  • Benign obstruction
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2017

First Posted

July 26, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)