AXIOS Stent With Electrocautery Enhanced Delivery System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02146352

Enrollment

Registered

2014-05-23

Start date

2014-06-30

Completion date

2015-03-31

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Pseudocyst(s)

Keywords

Pancreatic pseudocyst

Brief summary

The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.

Interventions

DEVICEAXIOS Stent with Electrocautery Enhanced Delivery System

Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age between 18 and 75 years old, male or female 2. Eligible for endoscopic intervention 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. Symptomatic pancreatic pseudocyst having the following characteristics: * Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound). * Adherent to bowel wall, and * ≥70% fluid content 5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent. 6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion criteria

1. The fluid collection to be drained is an immature pseudocyst 2. The fluid collection to be drained is a cystic neoplasm 3. The fluid collection to be drained is a pseudoaneurysm 4. The fluid collection to be drained is a duplication cyst 5. The fluid collection to be drained is a non-inflammatory fluid collection 6. There is more than one pseudocyst requiring drainage 7. Abnormal coagulation: * INR \> 1.5 and not correctable * presence of a bleeding disorder * platelets \< 50,000/mm3 8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 12. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Design outcomes

Primary

Measure	Time frame	Description
Safety/Adverse Event Outcome Measure 6	Index procedure through 1-week post-stent removal	Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure
Safety/Adverse Event Outcome Measure 1	Index procedure through 1-week post-stent removal	Freedom from access site-related bleeding requiring transfusion
Safety/Adverse Event Outcome Measure 2	Index procedure through 1-week post-stent removal	Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety/Adverse Event Outcome Measure 3	Index procedure through 1-week post-stent removal	Freedom from surgery for access-site related perforation
Safety/Adverse Event Outcome 4	Index procedure through 1-week post-stent removal	Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
Safety/Adverse Event Outcome Measure 5	Index procedure through 1-week post-stent removal	Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal

Secondary

Measure	Time frame	Description
Lumen Patency Outcome Measure	30 and/or 60 days post-procedure	Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.
Technical Success Outcome Measure 1	Index Procedure	Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System
Clinical Success Outcome Measure	30 or 60 days post-procedure	Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days
Technical Success Outcome Measure 2	30 or 60 Day Post-procedure	Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps
Stent Retention Outcome Measure	30 or 60 days post-procedure	Stent Retention: The stent must remain in place for up to 60 days

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treatment AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.	30
Total	30

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1
Overall Study	Patient entered hospice care	1

Baseline characteristics

Characteristic	Treatment
Age, Continuous	52.0 years STANDARD_DEVIATION 14.9
Height	67.3 inches STANDARD_DEVIATION 4.3
Region of Enrollment United States	30 participants
Sex: Female, Male Female	13 Participants
Sex: Female, Male Male	17 Participants
Weight	172.9 pounds STANDARD_DEVIATION 36.8

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 30
serious Total, serious adverse events	13 / 30