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Completed

NCT Number: NCT02730663

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.

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Key information

Conditions

Pancreatic Pseudocyst Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, Gyeonggi-do, South Korea

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About this study

'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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Niti-S SPAXUS Stent

Device

Endoscopic Ultrasound-Guided Transluminal drainage

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of Participants With Technical Success

    Time frame: Day 1

    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.

  2. Number of Participants With Stent Lumen Patency

    Time frame: up to 60 days (at stent removal, Day 30 or 60)

    Stent lumen patency will be evaluated by endoscopy.

  3. Number of Participants With Stent Removal Success

    Time frame: up to 60 days (at stent removal, Day 30 or 60)

    Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.

  4. Procedure Time

    Time frame: 1 day

    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)

  5. Number of Participants With Procedural/Device Related Serious Adverse Events

    Time frame: up to 90 days (at Day 20 post stent removal)

    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

  6. Other Adverse Events

    Time frame: up to 90 days (at Day 20 post stent removal)

    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.

Sponsors and collaborators

Lead sponsor

Taewoong Medical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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