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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niti-S SPAXUS Stent | Experimental | Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niti-S SPAXUS Stent | Device | Endoscopic Ultrasound-Guided Transluminal drainage |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Ho Moon, PhD, MD | Soon Chun Hyang University | Principal Investigator |
| Sang Soo Lee, PhD, MD | Asan Medical Center | Principal Investigator |
| Jong Kyun Lee, PhD, MD | Samsung Medical Center | Principal Investigator |
| Seung-Ok Lee, PhD, MD | Chonbuk National University Hospital | Principal Investigator |
| Chang Min Cho, PhD, MD | Kyungpook National University Medical Center | Principal Investigator |
| Se Woo Park, PhD, MD | Hallym University Dongtan Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | Gyeonggi-do | 14584 | South Korea | ||
| Hallym University Dongtan Sacred Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31152738 | Derived | 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. |
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Oct, 2016
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It took about 15 months from the approval of the Ministry of Food and Drug Safety(MFDS) and the IRB, including the subject enrollment period of about 13 months and the follow-up period of 2 months at maximum.
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| ID | Title | Description |
|---|---|---|
| FG000 | Niti-S SPAXUS Stent | Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Niti-S SPAXUS Stent | Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Success | Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT) | 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 | Posted | Number | participants | at stent removal (Day 30 or Day 60) |
|
3months
An "Adverse Event (AE)" refers to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Serious Adverse Event /Adverse Device Effect refers to the adverse events or adverse device effects occurred due to the investigational device, which is applicable to any of the consequences.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niti-S SPAXUS Stent | Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal bleeding | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain etc. | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiYoung Ahn/Assistant manager | Taewoong Medical Co., Ltd. | +82-70-4649-1624 | 628 | sarahahn@stent.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2016 | Apr 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010192 | Pancreatic Pseudocyst |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
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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.
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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) |
| Hwaseong-si |
| Gyeonggi-do |
| 18450 |
| South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Chonbook National University Hospital | Jeonju | 54907 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Inter-Quartile Range | cm |
|
| Body weight | Mean | Inter-Quartile Range | kg |
|
| History of smoking | Number | participants |
|
| Alcohol drinking | Number | participants |
|
| History of allergy | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | If the stent is deployed successfully in the gastrointestinal tract and the pseudocyst, and if the drainage is confirmed visually, it is considered technically successful | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Stent Lumen Patency | Stent lumen patency will be evaluated by endoscopy. | The stent lumen patency will be evaluated by the investigator at Day 30 or 60 (± 10 days) after the procedure of the Niti-S SPAXUS stent through clinical symptoms and endoscopy. | Posted | Count of Participants | Participants | up to 60 days (at stent removal, Day 30 or 60) |
|
|
|
| Secondary | 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. | When the Niti-S SPAXUSTM Stent is successfully removed by using forceps or snare through endoscopy as the treatment is succeeded clinically at Day 30 or 60 (± 10 days) according to standard procedures and the criteria for stent removal are met, it is considered as the stent removal success. | Posted | Count of Participants | Participants | up to 60 days (at stent removal, Day 30 or 60) |
|
|
|
| Secondary | 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) | The time is measured from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. | Posted | Mean | Standard Deviation | sec | 1 day |
|
|
|
| Secondary | 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 |
| Posted | Number | participants | up to 90 days (at Day 20 post stent removal) |
|
|
|
| Secondary | 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. | 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. | Posted | Number | case | up to 90 days (at Day 20 post stent removal) |
|
|
|
| 0 |
| 35 |
| 14 |
| 35 |
| 29 |
| 35 |
| Aggravated Walled off necrosis | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA V20.0 | Systematic Assessment |
|
| Peripancreatic abscess | Infections and infestations | MedDRA V20.0 | Systematic Assessment |
|
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V20.0 | Systematic Assessment |
|
| Abdominal pain (LUQ pain) -> wall-off necrosis | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
|
| Infected pseudocyst | Infections and infestations | MedDRA V20.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA V20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
|
| Necrotizing pseudocyst | Gastrointestinal disorders | MedDRA V20.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA V20.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA V20.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA V20.0 | Systematic Assessment |
|
| Pyrexia etc. | General disorders | MedDRA V20.0 | Systematic Assessment |
|
| Cholelithiasis etc. | Hepatobiliary disorders | MedDRA V20.0 | Systematic Assessment |
|
| Pancreas infection etc. | Infections and infestations | MedDRA V20.0 | Systematic Assessment |
|
| Pancreatic leak | Injury, poisoning and procedural complications | MedDRA V20.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA V20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V20.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA V20.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V20.0 | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |