AXIOS Stent With Electrocautery Enhanced Delivery System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AXIOS Stent & Delivery System Study

NCT01419769

Pancreatic Pseudocyst(s)

COMPLETED NA

AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

NCT03767881

Cholecystitis, Acute

COMPLETED NA

AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

NCT03525808

Walled Off Pancreatic Necrosis

COMPLETED NA

NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

NCT00231283

Coronary Artery Disease

COMPLETED PHASE3

Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)

NCT04059536

Chronic Total Occlusion Atherosclerosis Coronary Artery Disease +1 more

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Pseudocyst(s)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

AXIOS Stent with Electrocautery Enhanced Delivery System

Group Type EXPERIMENTAL

AXIOS Stent with Electrocautery Enhanced Delivery System

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No