ComVi and D-type Stent in Malignant GOO | NCT01839292

Studies
ComVi and D-type Stent in Malignant GOO

NCT01839292

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Apr 24, 2013Estimated

Enrollment

89Actual

Phase

Not Applicable

Conditions

Gastric Outlet Obstruction

Interventions

uncovered D-type stent insertion
double-layered ComVi stent insertion

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Not provided

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2013

Last Update Posted Date

Apr 24, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sun Gyo Lim, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Name	Class
National Cancer Center, Korea	OTHER_GOV
Kyungpook National University Hospital	OTHER
Hallym University	OTHER
The Catholic University of Korea

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
uncovered D-type stent	Active Comparator	uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction	Device: uncovered D-type stent insertion
double-layered ComVi stent	Active Comparator	double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration	Device: double-layered ComVi stent insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uncovered D-type stent insertion	Device		uncovered D-type stent
double-layered ComVi stent insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the stent patency time from stent insertion to restenosis due to stent malfunction or death		Up to 1 years

Secondary Outcomes

Measure	Description	Time Frame
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate		up to 1 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults 18 years of age or older
obstructive symptoms due to unresectable malignant GOO
a Karnofsky performance score of more than 30 (13)

Exclusion Criteria:

history of a previous SEMS insertion
the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
a life expectancy of less than 1 month after SEMS insertion
history of gastric surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Hong Kim, M.D., Ph.D.	Ajou University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Hospital		Suwon		443-721	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D017219	Gastric Outlet Obstruction

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided