AXIOS Stent With Electrocautery Enhanced Delivery System

Xlumena

Status: Completed

Conditions: Pancreatic Pseudocyst(s)

Treatments: Device: AXIOS Stent with Electrocautery Enhanced Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146352

CP201303

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment

Experimental group

Description:

AXIOS Stent with Electrocautery Enhanced Delivery System

Treatment:

Device: AXIOS Stent with Electrocautery Enhanced Delivery System