AXIOS™ Stent for Gastric Outlet Obstruction

Recruiting at 14 trial locations

Overseen By Evelyne Ho, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Anticoagulants

Disqualifiers: Gastric cancer, Pregnancy, Ascites, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: During the procedure

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests the safety and effectiveness of a special metal stent, the AXIOS™ Stent, for individuals with a blocked stomach outlet due to non-removable cancer. The stent is placed using EUS-guided gastroenterostomy, which creates a new pathway for food to pass from the stomach to the small intestine. This trial is suitable for those with severe blockages that prevent normal eating and who qualify for endoscopic procedures. Participants must have a blockage caused by non-removable cancer and be able to undergo the specific endoscopic procedure for stent placement. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for those with limited alternatives.

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 prior data suggests that the AXIOS™ Stent is safe for managing gastric outlet obstruction?

Research has shown that the AXIOS™ stent is generally safe for people. In studies where it was used for other conditions, such as draining fluid from the pancreas, patients tolerated it well. Although some patients experienced side effects, these were usually manageable. This suggests the treatment could be safe for those considering it for stomach blockage. Since this trial is not in its early stages, researchers have confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AXIOS™ Stent and Electrocautery Enhanced Delivery System for gastric outlet obstruction because it offers a minimally invasive alternative to traditional surgical options. Unlike standard treatments, which often involve open surgery or endoscopic balloon dilation, this system uses a novel EUS-guided gastroenterostomy technique. This method allows for direct drainage using a lumen-apposing metal stent, potentially reducing recovery time and improving patient comfort. Additionally, the electrocautery-enhanced delivery system enhances precision, making it a promising option for patients with malignant, unresectable neoplasms causing obstruction.

What evidence suggests that the AXIOS™ Stent is effective for gastric outlet obstruction?

Studies have shown that the AXIOS™ stent can help people with gastric outlet obstruction, a blockage that prevents food from leaving the stomach. Research indicates that the stent improves symptoms by opening the blocked area. This improvement is measured by an increase in the Gastric Outlet Obstruction Score (GOOS), which tracks how well food moves through the stomach. The AXIOS™ stent's special shape helps it stay in place and reduces the risk of slipping. Previous patients experienced long-lasting relief from their symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

Shayan Irani, MBBS, MD

Principal Investigator

Virginia Mason Medical Center

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

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

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

Published Research Related to This Trial

Fluoroscopically guided placement of uncovered metal stents for treating gastric outlet and duodenal obstructions was found to be 100% technically successful, with 12 out of 14 patients able to maintain oral intake for periods ranging from 7 to 270 days.

The procedure was deemed safe, with no immediate complications reported, although careful patient selection is necessary as some may not benefit from the stenting, particularly in benign cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gastric outlet and duodenal obstructions with uncovered expandable metal stents. Huang, Q., Dai, DK., Qian, XJ., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Malignant Gastric Outlet Obstruction with Expandable Metallic Stent Placement. Wang, ZY., Sun, LW., Wu, JL., et al.[2020]

In a study of 29 patients with unresectable malignant gastric outlet obstruction, the use of a long delivery system for a self-expanding coil stent was successful in 89.7% of cases, demonstrating its efficacy in palliative care.

After stent insertion, 96.3% of patients experienced symptomatic improvement, particularly in food ingestion and vomiting, indicating a significant enhancement in quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-expanding coil stent with a long delivery system for palliation of unresectable malignant gastric outlet obstruction: a prospective study. Kim, JH., Yoo, BM., Lee, KJ., et al.[2004]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endoscopic self-expanded metal stent for gastric outlet obstruction:a ten-year experience]. Zhong, YS., Yao, LQ., Xu, MD., et al.[2019]

The Hot AXIOS system for EUS-guided drainage of pancreatic fluid collections (PFCs) demonstrated a high technical success rate of 100% and a clinical success rate of 93.3% in a study of 30 patients, indicating its efficacy in treating conditions like pancreatic pseudocysts and walled-off necrosis.

While the procedure was generally safe, with most complications being manageable, 46.7% of patients experienced PFC-associated infections, and the likelihood of achieving complete remission of PFCs within one month was significantly higher in patients with a history of pancreatitis more than six months prior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Chinese prospective multicenter cohort study evaluating EUS-guided drainage of pancreatic fluid collections using the Hot AXIOS system. Li, P., Zhang, Z., Wang, S., et al.[2023]

The AXIOS stent and electrocautery-enhanced delivery system can effectively create an enterocolostomy to bypass small bowel obstructions in patients with recurrent malignant bowel obstruction, providing a less invasive alternative to surgery.

In a case involving a 72-year-old patient unfit for surgery, this novel approach successfully resolved the obstruction, highlighting its potential as a safe and effective intervention for managing distressing symptoms in end-stage cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided creation of an enterocolostomy to relieve malignant bowel obstruction. Mir, A., Parekh, PJ., Shakhatreh, M., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula. Auriemma, F., De Marco, A., Repici, A., et al.[2023]

Self-expanding metal stents (SEMS) were successfully inserted in 22 out of 23 patients with gastric outlet obstruction, with 45% of patients able to return to a normal diet, indicating their effectiveness in palliating this condition.

The study found no immediate complications from the stent insertion, although 27% of patients required reintervention due to issues like inadequate stent expansion and tumor ingrowth, highlighting the need for careful monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expandable metal stents for the palliation of malignant gastroduodenal obstruction. Razzaq, R., Laasch, HU., England, R., et al.[2019]

In a study of 260 patients with malignant gastric outlet obstruction, secondary gastroduodenal stent placement was found to be effective, achieving a technical success rate of 100% and a clinical success rate of 86.2%.

However, the procedure carries risks, with gastrointestinal perforation being the most significant complication, occurring in 13.8% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction. Sasaki, T., Isayama, H., Nakai, Y., et al.[2016]

The Hot AXIOS™ system for EUS-guided drainage showed a high technical success rate of 97.7% in 45 patients, indicating its effectiveness for managing pancreatic fluid collections, gallbladder drainage, and biliary drainage.

Clinical success was achieved in 86.4% of cases, with a relatively low adverse event rate of 11.4%, suggesting that this new lumen-apposing metal stent (LAMS) system is both safe and effective when used by experienced endoscopists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided transmural drainage by cautery-tipped lumen-apposing metal stent: exploring the possible indications. Anderloni, A., Leo, MD., Carrara, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648116/

The Role of Luminal Apposing Metal Stents on ... The present paper reviews procedural techniques and clinical outcomes of EUS-GE in the context of both malignant and benign GOOs.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06174805

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction ... Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6102456/

Current uses and outcomes of lumen-apposing metal stents The lumen-apposing metal stent (LAMS) is a recently developed device. It has a “barbell” shape with flanged ends that give it a theoretically very low risk of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468448124001395

Buried lumen-apposing metal stent following EUS-guided ... Buried lumen-apposing metal stent following EUS guided gastrojejunostomy: A rare adverse event and its management.

5. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-022-00409-z

Hybrid gastroenterostomy using a lumen-apposing metal stent ... Durability and long-term outcomes of direct EUS-guided gastroenterostomy using lumen-apposing metal stents for gastric outlet obstruction.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9258023/

Adverse events associated with AXIOS stents The AXIOS stent is indicated for transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts and symptomatic walled off necrosis.

7. gutnliver.org gutnliver.org/journal/view.html?pn=myread&uid=2276&vmd=Full

The Efficacy and Safety of Endoscopic Ultrasound-Guided ... Lumen-apposing metal stents (LAMS) are designed to provide stable anchorage across non-adherent luminal structures in apposition, potentially ...