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Sponsor Decision
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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.
The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement. | Through study completion, an average of 1 year |
| Primary Technical Success Endpoint | Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. | During the procedure |
| Primary Effectiveness Endpoint | 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 placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first. | through 14 days after procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, and 12 months | A patient undergoing reintervention for GOO is considered a failure of clinical success | Through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shayan Irani, MBBS, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Mayo Clinic |
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| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Time to resumption of oral intake after stent placement. | Immediately after the procedure |
| Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable) | Immediately after the procedure |
| Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, and 12 months | Through study completion, an average of 1 year |
| Incidence of Device Deficiencies | Including but not limited to stent migration/misplacement, stent occlusion, leakage at site of stent placement. | Immediately after the procedure |
| Incidence of Reintervention for GOO | defined as need for repeat treatment for persistent or recurrent GOO symptoms | Immediately after the procedure |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| New York Presbyterian/ Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| UZ Leuven | Leuven | Belgium |
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246-092 | Brazil |
| McGill University Health Care | Montreal | H3Z 2E9 | Canada |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Asian Institute of Gastroenterology | Hyderabad | India |