A Study To Evaluate The Effectiveness And Safety Of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

Study Overview

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

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.

'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.

Pancreatic Pseudocyst

DEVICE: Niti-S SPAXUS Stent

SPAXUS-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-03-28	Results First Submitted 2018-06-19	Last Update Submitted that met QC Criteria 2019-09-09
First Submitted that Met QC Criteria 2016-03-31	Results First Submitted that Met QC Criteria 2019-04-08	Last Update Posted (ACTUAL) 2019-09-17
First Posted (ACTUAL) 2016-04-06	Results First Posted 2019-07-01	Last Verified 2019-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Niti-S SPAXUS Stent Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)	DEVICE: Niti-S SPAXUS Stent Endoscopic Ultrasound-Guided Transluminal drainage

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Niti-S SPAXUS Stent

Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)

DEVICE: Niti-S SPAXUS Stent

Endoscopic Ultrasound-Guided Transluminal drainage

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

Secondary Outcome Measures	Measure Description	Time Frame
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.	Day 1
Number of Participants With Stent Lumen Patency	Stent lumen patency will be evaluated by endoscopy.	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.	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)	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	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.	up to 90 days (at Day 20 post stent removal)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jong Ho Moon, PhD, MD, Soon Chun Hyang University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record