AXIOS™ Gastroenterostomy för gastriskt utloppsobstruktion IDE
En prospektiv multicenter, enarmsstudie av endoskopisk ultraljudsvägledd gastroenterostomi med lumen-apposing metallstent för obstruktion av gastriskt utlopp från maligna ooperbar sjukdom
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Leuven, Belgien
- UZ Leuven
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São Paulo, Brasilien, 01246-092
- Instituto do Cancer do Estado de Sao Paulo
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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New York
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New York, New York, Förenta staterna, 10065
- New York Presbyterian/ Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburg Medical Center
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Washington
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Seattle, Washington, Förenta staterna, 98101
- Virginia Mason Medical Center
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Hyderabad, Indien
- Asian Institute of Gastroenterology
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Montreal, Kanada, H3Z 2E9
- McGill University Health Care
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200433
- Shanghai Changhai Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Gastric outlet obstruction from unresectable malignant neoplasm
- Eligible for endoscopic intervention
- GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
- 18 years of age or older
- 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:
- Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
- Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
- Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
- Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
- Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
- Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
- Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
- Ascites Grade ≥ 2 confirmed by cross-sectional imaging
- Vessels located within a two-centimeter radius of the device insertion location
- History of multiple abdominal surgeries and/or evidence of small bowel adhesions
- Allergic to any of the device materials
- Contraindications to use of electrical devices
- Pregnancy
- Prisoners and other vulnerable populations
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
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 |
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serious Adverse Events
Tidsram: Through study completion, an average of 1 year
|
The proportion of subjects with one or more 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
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Technical Success
Tidsram: During the procedure
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The proportion of subjects that demonstrate technical 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
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Primary Effectiveness Endpoint
Tidsram: through 14 days after procedure
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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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dags för återupptagande av oralt intag efter stentplacering.
Tidsram: Omedelbart efter proceduren
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Omedelbart efter proceduren
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Dags att starta eller återuppta kemoterapi efter placering av AXIOSTM stent (i tillämpliga fall)
Tidsram: Omedelbart efter proceduren
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Omedelbart efter proceduren
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Förändring i livskvalitetspoäng (SF-12 frågeformulär) från baslinjen till 30 dagar, 3 månader, 6 månader och 12 månader
Tidsram: Genom avslutad studie i snitt 1 år
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Genom avslutad studie i snitt 1 år
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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
Tidsram: Through study completion, an average of 1 year
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A patient undergoing reintervention for GOO is considered a failure of clinical success |
Through study completion, an average of 1 year
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Incidence of Device Deficiencies
Tidsram: Immediately after the procedure
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Including but not limited to stent migration/misplacement, stent occlusion, leakage at site of stent placement. |
Immediately after the procedure
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Incidence of Reintervention for GOO
Tidsram: Immediately after the procedure
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defined as need for repeat treatment for persistent or recurrent GOO symptoms |
Immediately after the procedure
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shayan Irani, MBBS, MD, Virginia Mason Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E7152
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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