Trial Outcomes & Findings for AXIOS Stent & Delivery System Study (NCT NCT01419769)
NCT ID: NCT01419769
Last Updated: 2015-09-21
Results Overview
Subjects are free of access site-related bleeding requiring transfusion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Through the duration of the 1-week post-stent removal study period
Results posted on
2015-09-21
Participant Flow
Participant milestones
| Measure |
AXIOS Stent and Delivery System
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
AXIOS Stent and Delivery System
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Overall Study
Did not receive the AXIOS stent
|
3
|
|
Overall Study
Not evaluable due to pigtail stents
|
1
|
Baseline Characteristics
AXIOS Stent & Delivery System Study
Baseline characteristics by cohort
| Measure |
AXIOS Stent and Delivery System
n=33 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Age, Continuous
|
52.6 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Height
|
67.4 inches
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Weight
|
169.5 pounds
STANDARD_DEVIATION 43.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Intent-to-Treat population
Subjects are free of access site-related bleeding requiring transfusion
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=33 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Safety - Freedom From Major Complications: Access Site-related Bleeding
|
100 percentage of patients
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Per protocol population
Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=29 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
|
|---|---|
|
Safety - Freedom From Major Complications: Access Site-related Infection
|
96.6 percentage of patients
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Intent-to-Treat population
Subjects are free of surgery for access-site related perforation
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=33 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Safety - Freedom From Major Complications: Perforation
|
100 percentage of patients
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Per protocol population of subjects with stent successfully placed
Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=29 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Safety - Freedom From Major Complications: Stent Migration/Dislodement
|
96.6 percentage of patients
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Per protocol population
Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=29 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
|
|---|---|
|
Safety - Freedom From Major Complications: Tissue Injury
|
100 percentage of patients
|
PRIMARY outcome
Timeframe: Through the duration of the 1-week post-stent removal study periodPopulation: Intent-to-Treat population
Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=33 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Safety - Freedom From Major Complications: SAE's
|
84.8 percentage of patients
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SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Patients treated per protocol with successful stent placement.
Stent lumen patency at 30 days and/or 60 days.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=29 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days
|
93.1 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Patients who had AXIOS stent successfully placed during index procedure.
AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=30 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Effectiveness: Stent Removability at 30 Days and/or 60 Days
|
96.7 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Intent-to-Treat population
Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=33 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Effectiveness: Technical Success
Placement of AXIOS stent
|
30 participants
|
|
Effectiveness: Technical Success
Removal of AXIOS stent using standard endosc snare
|
29 participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Patients treated per protocol.
Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Outcome measures
| Measure |
AXIOS Stent and Delivery System
n=29 Participants
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
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|---|---|
|
Clinical Success
|
86.2 percentage of patients
|
Adverse Events
AXIOS Stent and Delivery System
Serious events: 16 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AXIOS Stent and Delivery System
n=33 participants at risk
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
6/33 • Number of events 6 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Abdominal pain and nausea after eating
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Abdominal pain and vomiting after eating
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Abdominal pain, nausea, and vomiting after eating
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Abdominal pain and syncope, GI bleeding
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Nausea and vomiting only after eating
|
6.1%
2/33 • Number of events 2 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Infections and infestations
Infection
|
9.1%
3/33 • Number of events 3 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Pancreatitis
|
6.1%
2/33 • Number of events 2 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Cardiac disorders
Chest pain
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Cardiac disorders
Chest pain and pressure, shortness of breath, heart palpitations
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Infections and infestations
Fever
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
GI Bleed
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Nervous system disorders
Headache and lightheadedness/ dizziness
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Intraperitoneal air
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Musculoskeletal and connective tissue disorders
Left shoulder/ back pain
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Cardiac disorders
Respiratory failure
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
General disorders
Severe dehydration
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Mucus overgrowth
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
Other adverse events
| Measure |
AXIOS Stent and Delivery System
n=33 participants at risk
AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
27.3%
9/33 • Number of events 11 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Nausea after eating
|
15.2%
5/33 • Number of events 5 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Infections and infestations
Fever
|
12.1%
4/33 • Number of events 4 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Vomiting after eating
|
9.1%
3/33 • Number of events 3 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Number of events 3 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • Number of events 3 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
General disorders
Lightheadedness/ dizziness
|
6.1%
2/33 • Number of events 2 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
New pancreatic pseudocyst
|
6.1%
2/33 • Number of events 2 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Black stool
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
General disorders
Bleeding
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Bloating
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
General disorders
Chills
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
General disorders
Flank pain
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
J-tube clogged
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Gastrointestinal disorders
Peripancreatic inflammation
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.0%
1/33 • Number of events 1 • From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must wait 9 months after close of study for Sponsor to present collaborative publication. If Sponsor does not publish within 9 months after close of study, PI is free to publish institution's results at that time. Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 6 months from the date the PI receives the objection. The Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER