Malignant Gastric Outlet ObstructionSEMSNCT02440724
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
A study testing Winged stent (partially covered) and Winged stent (uncovered) in people with Malignant Gastric Outlet Obstruction, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Gastric Outlet Obstruction
- What is being tested?
- Winged stent (partially covered) and Winged stent (uncovered)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric outlet obstruction symptom
- Diagnosis of gastric outlet obstruction by radiologist or endoscopist
- Gastric outlet obstruction by malignant disease
- Aged over 19
- Informed consent
Who cannot join
- Gastric outlet obstruction by benign disease or infectious disease
- Could not endoscopic intervention by poor general condition
- Refusal of patient
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 138-736
myungeun lee, BA, +82-2-3010-7190, lme23@amc.seoul.kr
Ji Yong Ahn, Professor
About this study
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
- Conditions
- Malignant Gastric Outlet Obstruction
- Being tested
- Winged stent (partially covered), Winged stent (uncovered)
- Keywords
- winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winged stent (partially covered)Device
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
Winged stent (uncovered)Device
A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
| Study group | Role | What they receive |
|---|---|---|
| winged stent group | Experimental | participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS). Receives: Device: Winged stent (partially covered); Device: Winged stent (uncovered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Measured: up to 16 weeks from stent insertion
Secondary outcomes (3)
Evaluate the technical success rate of SEMS insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Measured: up to 16 weeks from stent insertion
Evaluate the clinical success rate of SEMS insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Measured: up to 16 weeks from stent insertion
Difference of insertion time between previous stent insertion and new designed stent
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yong Ahn, Asan Medical Center
- Investigators
- Ji Yong Ahn, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440724
- Sponsor's protocol ID
- 2014-0820
- Acronym
- SEMS
- Status last verified
- May 2015
- First submitted
- 4 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
- ClinicalTrials.gov ID
- NCT02440724
- Acronym / sponsor ID
- SEMS / 2014-0820
- Conditions
- Malignant Gastric Outlet Obstruction
- Keywords
- winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| winged stent group | Experimental | Device: Winged stent (partially covered), Device: Winged stent (uncovered)participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gastric outlet obstruction symptom
- Diagnosis of gastric outlet obstruction by radiologist or endoscopist
- Gastric outlet obstruction by malignant disease
- Aged over 19
- Informed consent
Key exclusion criteria (3 listed)
- Gastric outlet obstruction by benign disease or infectious disease
- Could not endoscopic intervention by poor general condition
- Refusal of patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winged stent (partially covered)A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction. | Device | winged stent group |
| Winged stent (uncovered)A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction. | Device | winged stent group |
Primary outcome
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
Time frame: up to 16 weeks from stent insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
3 secondary outcomes
Evaluate the technical success rate of SEMS insertion
Time frame: up to 16 weeks from stent insertion
Evaluate the clinical success rate of SEMS insertion
Time frame: up to 16 weeks from stent insertion
Difference of insertion time between previous stent insertion and new designed stent
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Yong Ahn, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winged stent (partially covered) and Winged stent (uncovered) in people with Malignant Gastric Outlet Obstruction, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact myungeun lee, BA (+82-2-3010-7190, lme23@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate(stent migration and tumor ingrowth) of new designed winged stent (time frame: up to 16 weeks from stent insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.