Trial Outcomes & Findings for AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE (NCT NCT03767881)
NCT ID: NCT03767881
Last Updated: 2023-02-17
Results Overview
Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Up to 15 weeks
Results posted on
2023-02-17
Participant Flow
Participant milestones
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
Patients will receive the AXIOS stent for the treatment of
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
|
25
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Baseline characteristics by cohort
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients will receive the AXIOS stent for the treatment of
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Age, Continuous
|
75.2 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
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Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Belgium
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10 participants
n=5 Participants
|
|
Region of Enrollment
United States
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20 participants
n=5 Participants
|
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Weight
|
76.4 kg
STANDARD_DEVIATION 17.8 • n=5 Participants
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Height
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168.6 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
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BMI
|
26.9 kg/m²
STANDARD_DEVIATION 6.3 • n=5 Participants
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PRIMARY outcome
Timeframe: Up to 15 weeksTime to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Number of Days to Resolution of Acute Cholecystitis
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5.30 days
Standard Deviation 14.90
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SECONDARY outcome
Timeframe: Through study completion, Up to 15 weeksRate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Rate of Re-interventions
|
5 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Stent placement through stent removal, approximately 60 daysStent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=22 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Stent Patency
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22 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative (stent placement)Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Number of Participants With Successful Technical Stent Placement.
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28 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative (stent removal)Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=19 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Number of Participants With Successful Technical Stent Removal.
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19 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 15 weeksRecurrence of acute cholecystitis and its management post AXIOS stent removal
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Acute Cholecystitis Recurrence
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3 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 15 weeksNumber of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis
Outcome measures
| Measure |
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
n=30 Participants
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
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|---|---|
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Number of Cumulative Hospital and ICU Days
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8.30 Days
Standard Deviation 7.14
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Adverse Events
AXIOS Stent and Electrocautery Enhanced Delivery System
Serious events: 16 serious events
Other events: 22 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
n=30 participants at risk
Patients will receive the AXIOS stent for the treatment of
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Renal and urinary disorders
Acute kidney injury
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10.0%
3/30 • Number of events 3 • 16 months
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Cardiac disorders
Cardiac failure
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6.7%
2/30 • Number of events 2 • 16 months
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Nervous system disorders
Syncope
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3.3%
1/30 • Number of events 1 • 16 months
|
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Infections and infestations
Enterococcal infection
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3.3%
1/30 • Number of events 1 • 16 months
|
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Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
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3.3%
1/30 • Number of events 1 • 16 months
|
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Investigations
Haemoglobin decreased
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3.3%
1/30 • Number of events 1 • 16 months
|
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Hepatobiliary disorders
Cholecystitis
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3.3%
1/30 • Number of events 1 • 16 months
|
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Metabolism and nutrition disorders
Dehydration
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3.3%
1/30 • Number of events 1 • 16 months
|
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Gastrointestinal disorders
Abdominal pain upper
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3.3%
1/30 • Number of events 1 • 16 months
|
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Renal and urinary disorders
Urinary retention
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3.3%
1/30 • Number of events 1 • 16 months
|
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Infections and infestations
Pyelonephritis
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3.3%
1/30 • Number of events 1 • 16 months
|
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Vascular disorders
Deep vein thrombosis
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3.3%
1/30 • Number of events 1 • 16 months
|
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Injury, poisoning and procedural complications
Traumatic liver injury
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3.3%
1/30 • Number of events 1 • 16 months
|
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Hepatobiliary disorders
Cholangitis
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3.3%
1/30 • Number of events 1 • 16 months
|
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Investigations
C-reactive protein increased
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3.3%
1/30 • Number of events 1 • 16 months
|
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Gastrointestinal disorders
Abdominal pain
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3.3%
1/30 • Number of events 1 • 16 months
|
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Investigations
Troponin T increased
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3.3%
1/30 • Number of events 1 • 16 months
|
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Infections and infestations
Cystitis
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3.3%
1/30 • Number of events 1 • 16 months
|
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Nervous system disorders
Cerebrovascular accident
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3.3%
1/30 • Number of events 1 • 16 months
|
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Blood and lymphatic system disorders
Splenic infarction
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3.3%
1/30 • Number of events 1 • 16 months
|
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Psychiatric disorders
Mental status changes
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Infections and infestations
Pneumonia
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Constipation
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Infections and infestations
Sepsis
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Vascular disorders
Hypotension
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Injury, poisoning and procedural complications
Fall
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Blood and lymphatic system disorders
Anaemia
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3.3%
1/30 • Number of events 1 • 16 months
|
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Blood and lymphatic system disorders
Leukocytosis
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Hepatobiliary disorders
Bile duct stone
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3.3%
1/30 • Number of events 1 • 16 months
|
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Infections and infestations
Septic shock
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3.3%
1/30 • Number of events 1 • 16 months
|
|
Vascular disorders
Orthostatic hypotension
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3.3%
1/30 • Number of events 1 • 16 months
|
Other adverse events
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
n=30 participants at risk
Patients will receive the AXIOS stent for the treatment of
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Gastrointestinal disorders
Diarrhoea
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30.0%
9/30 • Number of events 9 • 16 months
|
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Investigations
C-reactive protein increased
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16.7%
5/30 • Number of events 6 • 16 months
|
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Infections and infestations
Urinary tract infection
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10.0%
3/30 • Number of events 3 • 16 months
|
|
Metabolism and nutrition disorders
Decreased appetite
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10.0%
3/30 • Number of events 3 • 16 months
|
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General disorders
Fatigue
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10.0%
3/30 • Number of events 3 • 16 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
2/30 • Number of events 2 • 16 months
|
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Renal and urinary disorders
Haematuria
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6.7%
2/30 • Number of events 2 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • Number of events 2 • 16 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2 • 16 months
|
Additional Information
Evelyne Ho, Clinical Project Manager
Boston Scientific
Phone: 1-978-483-8856
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place