67 Participants Needed

AXIOS™ Stent for Gastric Outlet Obstruction

Recruiting at 13 trial locations
WC
EH
Overseen ByEvelyne Ho, MPH, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the AXIOS™ Stent for treating gastric outlet obstruction?

Research shows that metal stents, like the AXIOS™ Stent, are effective in treating gastric outlet obstruction by helping to open blocked areas in the stomach. These stents have been used successfully in both benign and malignant cases, improving the ability to eat and digest food.12345

Is the AXIOS Stent safe for use in humans?

The Hot AXIOS system, which includes a cautery-enhanced stent, has been studied for safety in procedures like draining pancreatic fluid collections and gallbladder issues. Research indicates it is generally safe for these uses, suggesting it may be safe for other conditions as well.13678

How is the AXIOS™ Stent treatment different from other treatments for gastric outlet obstruction?

The AXIOS™ Stent with electrocautery-enhanced delivery is unique because it allows for a minimally invasive procedure using endoscopic ultrasound to create a bypass for obstructions, which can be particularly beneficial for patients who are not suitable for surgery. This approach contrasts with traditional surgical methods and other stent placements that may not use electrocautery or endoscopic ultrasound guidance.145910

What is the purpose of this trial?

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

Research Team

SI

Shayan Irani, MBBS, MD

Principal Investigator

Virginia Mason Medical Center

Eligibility Criteria

This trial is for individuals with gastric outlet obstruction or pyloric stenosis, which are conditions that block food from leaving the stomach. Participants must have symptoms due to a malignant tumor that cannot be removed by surgery.

Inclusion Criteria

GOOS of 0 or 1 (0 - no oral intake, 1 - liquids only)
Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm
See 2 more

Exclusion Criteria

Vessels located within 3.5-4 cm of the pathway from the device insertion location on the gastric wall to the device insertion location of the small bowel wall
Allergic to any of the device materials
Contraindications to use of electrical devices
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EUS-guided gastroenterostomy using the AXIOS lumen-apposing Metal Stent

During the procedure
1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and technical success, including serious adverse events and stent patency

4 weeks
1 visit (in-person)

Extended Follow-up

Participants are monitored for clinical success and device deficiencies over time

12 months
3 visits (in-person) at 3, 6, and 12 months

Treatment Details

Interventions

  • AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Trial Overview The trial is testing the AXIOS(TM) Stent and Electrocautery Enhanced Delivery System. It aims to see if this method is safe and successful in creating a new pathway for food to bypass the blocked area in patients' stomachs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemExperimental Treatment1 Intervention
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Electrocautery lumen-apposing metal stents, like the bi-flanged SpaxusTM stent, represent a novel and effective treatment for gastric outlet obstruction, which can occur due to various benign or malignant conditions.
This case report highlights the successful use of endoscopic ultrasound-guided gastroenterostomy with the SpaxusTM stent, demonstrating its potential as a minimally invasive option for improving gastric emptying in patients with obstruction.
Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula.Auriemma, F., De Marco, A., Repici, A., et al.[2023]
Endoscopic self-expanded metal stents have a high success rate of 98.2% in treating gastric outlet obstruction, allowing most patients to resume eating liquid and normal foods within days after the procedure.
The procedure is considered safe, with a low complication rate (14.5% experiencing pain and 25.5% with bleeding), and it provides a mean survival time of approximately 139 days for patients, making it an effective micro-invasive treatment option.
[Endoscopic self-expanded metal stent for gastric outlet obstruction:a ten-year experience].Zhong, YS., Yao, LQ., Xu, MD., et al.[2019]
In a study involving 9 patients with malignant gastric outlet obstruction, metallic stent placement was successful on the first attempt for all patients, demonstrating high efficacy in alleviating obstructive symptoms.
The mean stent patency was 53.4 days, with no instances of stent migration or occlusion during a 3-month follow-up, indicating that metallic stents are a reliable option for managing this condition.
Management of Malignant Gastric Outlet Obstruction with Expandable Metallic Stent Placement.Wang, ZY., Sun, LW., Wu, JL., et al.[2020]

References

Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula. [2023]
[Endoscopic self-expanded metal stent for gastric outlet obstruction:a ten-year experience]. [2019]
Management of Malignant Gastric Outlet Obstruction with Expandable Metallic Stent Placement. [2020]
Expandable metal stents for the palliation of malignant gastroduodenal obstruction. [2019]
Self-expanding coil stent with a long delivery system for palliation of unresectable malignant gastric outlet obstruction: a prospective study. [2004]
Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction. [2016]
Endoscopic ultrasound-guided transmural drainage by cautery-tipped lumen-apposing metal stent: exploring the possible indications. [2022]
A Chinese prospective multicenter cohort study evaluating EUS-guided drainage of pancreatic fluid collections using the Hot AXIOS system. [2023]
Endoscopic ultrasound-guided creation of an enterocolostomy to relieve malignant bowel obstruction. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment of gastric outlet and duodenal obstructions with uncovered expandable metal stents. [2019]
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