AXIOS™ Gastroenterostomi for gastrisk utløpsobstruksjon IDE
En prospektiv multisenter-, enarmsstudie av endoskopisk ultralyd-veiledet gastroenterostomi med lumentilpasset metallstent for obstruksjon av gastrisk utløp fra ondartet, ikke-opererbar sykdom
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Leuven, Belgia
- UZ Leuven
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São Paulo, Brasil, 01246-092
- Instituto do Cancer do Estado de Sao Paulo
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Montreal, Canada, H3Z 2E9
- McGill University Health Care
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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New York
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New York, New York, Forente stater, 10065
- New York Presbyterian/ Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburg Medical Center
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Washington
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Seattle, Washington, Forente stater, 98101
- Virginia Mason Medical Center
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Hyderabad, India
- Asian Institute of Gastroenterology
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200433
- Shanghai Changhai Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serious Adverse Events
Tidsramme: Through study completion, an average of 1 year
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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
Tidsramme: 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
Tidsramme: 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
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tid til gjenopptakelse av oralt inntak etter stentplassering.
Tidsramme: Umiddelbart etter prosedyren
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Umiddelbart etter prosedyren
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Tid for å starte eller gjenoppta kjemoterapi etter AXIOSTM stentplassering (der det er aktuelt)
Tidsramme: Umiddelbart etter prosedyren
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Umiddelbart etter prosedyren
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Endring i livskvalitetsscore (SF-12 spørreskjema) fra baseline til 30 dager, 3 måneder, 6 måneder og 12 måneder
Tidsramme: Gjennom studiegjennomføring i snitt 1 år
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Gjennom studiegjennomføring 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Immediately after the procedure
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defined as need for repeat treatment for persistent or recurrent GOO symptoms |
Immediately after the procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shayan Irani, MBBS, MD, Virginia Mason Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E7152
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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