Pancreatic PseudocystNCT02730663

A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

A study testing Niti-S SPAXUS Stent in people with Pancreatic Pseudocyst, run by Taewoong Medical Co., Ltd. at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Pancreatic Pseudocyst
What is being tested?: Niti-S SPAXUS Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 6 sitesSouth Korea
Study dates: 21 Mar 2016to 14 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage
Patient willing to provide written informed consent and comply with follow-up requirements

Who cannot join

Ineligible for endoscopic intervention
Pancreatic pseudocyst with severe internal septation
Platelet count < 60,000 cells/mm3 or international normalized ratio (INR) >1.5
Hemodynamic instability (e.g. shock)
Active infectious disease (e.g. endocarditis, meningitis)
Participating in any other investigational drug or device clinical trial within past 3 months
Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

South Korea6 sites

Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
Kyungpook National University Medical Center
Daegu, 41404
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
Chonbook National University Hospital
Jeonju, 54907
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351

Other trials in South Korea

About this study

Official title: A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst

Read the detailed description

'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.

Conditions: Pancreatic Pseudocyst
Being tested: Niti-S SPAXUS Stent
Keywords: Endoscopic ultrasound guided transluminal drainage
Medical subject headings: Pancreatic Pseudocyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Niti-S SPAXUS StentDevice
Endoscopic Ultrasound-Guided Transluminal drainage

Study groups in NCT02730663
Study group	Role	What they receive
Niti-S SPAXUS Stent	Experimental	Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Niti-S SPAXUS Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Success
Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)
Measured: at stent removal (Day 30 or Day 60)

Secondary outcomes (6)

Number of Participants With Technical Success
Technical success is defined as successful placement of the Niti-S SPAXUS stent across the gastric(or duodenal) wall to the pseudocyst with visualization of the pseudocyst fluid drainage through the stent by endoscopy.
Measured: Day 1
Number of Participants With Stent Lumen Patency
Stent lumen patency will be evaluated by endoscopy.
Measured: up to 60 days (at stent removal, Day 30 or 60)
Number of Participants With Stent Removal Success
Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.
Measured: up to 60 days (at stent removal, Day 30 or 60)
Procedure Time
Procedure time is measured as time from insertion until removal of endoscope. Procedure time 1: The time from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. (sec) Procedure time 2: The time from the puncture time to the point at which the ultrasound endoscope was removed. (sec)
Measured: 1 day
Number of Participants With Procedural/Device Related Serious Adverse Events
The incidence of serious adverse events related to the procedure or the Niti-S SPAXUSTM stent is assessed at Day 20 after the stent removal
Measured: up to 90 days (at Day 20 post stent removal)
Other Adverse Events
The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal.
Measured: up to 90 days (at Day 20 post stent removal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201614 Jun 2017

First posted6 Apr 2016 (estimated)
Study start21 Mar 2016
Primary completion14 Jun 2017
Study completion14 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic PseudocystStudies of the same condition, open and under way.
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
Model description: The investigational device (ID) 'Niti-S SPAXUS Stent' is used for drainage of cystic fluid by being connected to the pancreatic pseudocyst through human organs such as stomach or duodenum. It is composed with a stent made of nitinol and introducer system.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02730663
Sponsor's protocol ID: SPAXUS-001
Status last verified: Apr 2019
First submitted: 28 Mar 2016
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Oct, 2016

Publications

Song TJ, Lee SS, Moon JH, Choi HJ, Cho CM, Lee KH, Park SW, Kim SH, Lee SO, Lee YN, Lee JK. Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video). Gastrointest Endosc. 2019 Sep;90(3):507-513. doi: 10.1016/j.gie.2019.05.033. Epub 2019 May 30.
PubMed 31152738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst
ClinicalTrials.gov ID: NCT02730663
Acronym / sponsor ID: SPAXUS-001
Conditions: Pancreatic Pseudocyst
Keywords: Endoscopic ultrasound guided transluminal drainage
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Mar 2016 (actual)
Primary completion: 14 Jun 2017 (actual)
Study completion: 14 Jun 2017 (actual)
First posted: 6 Apr 2016 (estimated)
Results: Posted 1 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The investigational device (ID) 'Niti-S SPAXUS Stent' is used for drainage of cystic fluid by being connected to the pancreatic pseudocyst through human organs such as stomach or duodenum. It is composed with a stent made of nitinol and introducer system.

Arm	Type	Receives
Niti-S SPAXUS Stent	Experimental	Device: Niti-S SPAXUS StentNiti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage
Patient willing to provide written informed consent and comply with follow-up requirements

Key exclusion criteria (7 listed)

Ineligible for endoscopic intervention
Pancreatic pseudocyst with severe internal septation
Platelet count < 60,000 cells/mm3 or international normalized ratio (INR) >1.5
Hemodynamic instability (e.g. shock)
Active infectious disease (e.g. endocarditis, meningitis)

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
Niti-S SPAXUS StentEndoscopic Ultrasound-Guided Transluminal drainage	Device	Niti-S SPAXUS Stent

Primary outcome

Number of Participants With Clinical Success
Time frame: at stent removal (Day 30 or Day 60)
Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)

6 secondary outcomes

Number of Participants With Technical Success
Time frame: Day 1
Number of Participants With Stent Lumen Patency
Time frame: up to 60 days (at stent removal, Day 30 or 60)
Number of Participants With Stent Removal Success
Time frame: up to 60 days (at stent removal, Day 30 or 60)
Procedure Time
Time frame: 1 day
Number of Participants With Procedural/Device Related Serious Adverse Events
Time frame: up to 90 days (at Day 20 post stent removal)
Other Adverse Events
Time frame: up to 90 days (at Day 20 post stent removal)

Results and safety

Results posted to the registry on 1 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Niti-S SPAXUS Stent	36	35

Primary outcome: Number of Participants With Clinical Success

Time frame: at stent removal (Day 30 or Day 60). Number. Unit: participants

Measure	Niti-S SPAXUS Stent n = 34
Value	33

Niti-S SPAXUS Stent: Reference value: -0.07, p = 0.05, t-test, 2 sided

Population analysed: The analysis is performed in the subjects who underwent the Niti-S SPAXUS stent and have the results of effectiveness assessment at the time point of the stent removal among those who satisfy the inclusion • exclusion criteria, consented to participate in the study

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Niti-S SPAXUS Stent	14 of 35 (40%)	29 of 35 (82.9%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31152738Song TJ, Lee SS, Moon JH, Choi HJ, Cho CM, Lee KH, Park SW, Kim SH, Lee SO, Lee YN, Lee JK. Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video). Gastrointest Endosc. 2019 Sep;90(3):507-513. doi: 10.1016/j.gie.2019.05.033. Epub 2019 May 30.
Individual participant dataSharing planned: No. Oct, 2016

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RecruitingObservational study
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RecruitingObservational study
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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.

Jong Ho Moon, PhD, MD principal investigator

Soon Chun Hyang University

Sang Soo Lee, PhD, MD principal investigator

Asan Medical Center

Jong Kyun Lee, PhD, MD principal investigator

Samsung Medical Center

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Niti-S SPAXUS Stent in people with Pancreatic Pseudocyst, run by Taewoong Medical Co., Ltd. at 6 sites 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Success (time frame: at stent removal (Day 30 or Day 60)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730663, which also lists 1 linked publication.

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 17 Sep 2019.