Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent' (NCT NCT02730663)

Results Overview

Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

at stent removal (Day 30 or Day 60)

Results posted on

2019-09-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Niti-S SPAXUS Stent Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Niti-S SPAXUS Stent n=35 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Age, Continuous	52.51 years STANDARD_DEVIATION 13.22 • n=35 Participants
Sex: Female, Male Female	8 Participants n=35 Participants
Sex: Female, Male Male	27 Participants n=35 Participants
Region of Enrollment South Korea	35 participants n=35 Participants
Height	167.82 cm n=35 Participants
Body weight	64.34 kg n=35 Participants
History of smoking Current Smoker	13 participants n=35 Participants
History of smoking Ex-Smoker	10 participants n=35 Participants
History of smoking Non-Smoker	12 participants n=35 Participants
Alcohol drinking Current Drinker	13 participants n=35 Participants
Alcohol drinking Ex-Drinker	14 participants n=35 Participants
Alcohol drinking Non-Drinker	8 participants n=35 Participants
History of allergy Yes	2 participants n=35 Participants
History of allergy No	33 participants n=35 Participants

PRIMARY outcome

Timeframe: at stent removal (Day 30 or Day 60)

Population: 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

Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=34 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Number of Participants With Clinical Success	33 participants

SECONDARY outcome

Timeframe: Day 1

Population: 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

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.

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=34 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Number of Participants With Technical Success	33 Participants

SECONDARY outcome

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

Population: 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.

Stent lumen patency will be evaluated by endoscopy.

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=34 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Number of Participants With Stent Lumen Patency	34 Participants

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=34 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Number of Participants With Stent Removal Success	34 Participants

SECONDARY outcome

Timeframe: 1 day

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=34 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Procedure Time Procedure time 1	1074.88 sec Standard Deviation 618.30
Procedure Time Procedure time 2	618.12 sec Standard Deviation 341.63

SECONDARY outcome

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

Population: * Resulted in death or life threatening * Required inpatient hospitalization or prolongation of existing hospitalization ③ Resulted in persistent or significant disability/incapacity ④ Caused a congenital anomaly/birth defect

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

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=35 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Number of Participants With Procedural/Device Related Serious Adverse Events	14 participants

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Niti-S SPAXUS Stent n=35 Participants Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Other Adverse Events	154 case

Adverse Events

Niti-S SPAXUS Stent

Serious events: 14 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Niti-S SPAXUS Stent n=35 participants at risk Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Gastrointestinal disorders Upper gastrointestinal bleeding	2.9% 1/35 • Number of events 1 • 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.
Gastrointestinal disorders Aggravated Walled off necrosis	5.7% 2/35 • Number of events 2 • 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.
Metabolism and nutrition disorders Dehydration	2.9% 1/35 • Number of events 1 • 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.
Infections and infestations Peripancreatic abscess	2.9% 1/35 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer	2.9% 1/35 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain (LUQ pain) -> wall-off necrosis	2.9% 1/35 • Number of events 1 • 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.
Infections and infestations Infected pseudocyst	8.6% 3/35 • Number of events 3 • 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.
Nervous system disorders Cerebral infarction	2.9% 1/35 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Number of events 2 • 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.
Gastrointestinal disorders Necrotizing pseudocyst	5.7% 2/35 • Number of events 2 • 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.

Other adverse events

Other adverse events
Measure	Niti-S SPAXUS Stent n=35 participants at risk Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) Niti-S SPAXUS Stent: Endoscopic Ultrasound-Guided Transluminal drainage
Gastrointestinal disorders Abdominal pain etc.	68.6% 24/35 • Number of events 69 • 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.
Blood and lymphatic system disorders Thrombocytosis	2.9% 1/35 • Number of events 1 • 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.
Cardiac disorders Tachycardia	2.9% 1/35 • Number of events 1 • 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.
Eye disorders Visual impairment	2.9% 1/35 • Number of events 1 • 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.
General disorders Pyrexia etc.	48.6% 17/35 • Number of events 23 • 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.
Hepatobiliary disorders Cholelithiasis etc.	5.7% 2/35 • Number of events 2 • 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.
Infections and infestations Pancreas infection etc.	20.0% 7/35 • Number of events 7 • 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.
Injury, poisoning and procedural complications Pancreatic leak	2.9% 1/35 • Number of events 1 • 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.
Investigations Blood pressure decreased	14.3% 5/35 • Number of events 5 • 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.
Metabolism and nutrition disorders Decreased appetite	25.7% 9/35 • Number of events 12 • 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.
Musculoskeletal and connective tissue disorders Flank pain	17.1% 6/35 • Number of events 7 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	2.9% 1/35 • Number of events 1 • 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.

Additional Information

JiYoung Ahn/Assistant manager

Taewoong Medical Co., Ltd.

Phone: +82-70-4649-1624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place