AXIOS™ gastro-enterostomie voor obstructie van de maaguitgang IDE
Een prospectief multicenter, eenarmig onderzoek naar endoscopische echogeleide gastro-enterostomie met op het lumen gerichte metalen stent voor obstructie van de maaguitgang door kwaadaardige, niet-reseceerbare ziekten
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Leuven, België
- UZ Leuven
-
-
-
-
-
São Paulo, Brazilië, 01246-092
- Instituto do Cancer do Estado de Sao Paulo
-
-
-
-
-
Montreal, Canada, H3Z 2E9
- McGill University Health Care
-
-
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200433
- Shanghai Changhai Hospital
-
-
-
-
-
Hyderabad, Indië
- Asian Institute of Gastroenterology
-
-
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02115
- Brigham and Women's Hospital
-
-
Minnesota
-
Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
-
-
New York
-
New York, New York, Verenigde Staten, 10065
- New York Presbyterian/ Weill Cornell Medical Center
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburg Medical Center
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98101
- Virginia Mason Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Serious Adverse Events
Tijdsspanne: 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
|
|
Technical Success
Tijdsspanne: During the procedure
|
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
|
|
Primary Effectiveness Endpoint
Tijdsspanne: through 14 days after procedure
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Tijd voor hervatting van de orale inname na plaatsing van de stent.
Tijdsspanne: Direct na de procedure
|
Direct na de procedure
|
|
|
Tijd om chemotherapie te starten of te hervatten na plaatsing van de AXIOSTM-stent (indien van toepassing)
Tijdsspanne: Direct na de procedure
|
Direct na de procedure
|
|
|
Verandering in de kwaliteit van leven-score (SF-12-vragenlijst) vanaf de uitgangswaarde tot 30 dagen, 3 maanden, 6 maanden en 12 maanden
Tijdsspanne: Via afronding van de studie, gemiddeld 1 jaar
|
Via afronding van de studie, gemiddeld 1 jaar
|
|
|
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
Tijdsspanne: Through study completion, an average of 1 year
|
A patient undergoing reintervention for GOO is considered a failure of clinical success |
Through study completion, an average of 1 year
|
|
Incidence of Device Deficiencies
Tijdsspanne: Immediately after the procedure
|
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
Tijdsspanne: Immediately after the procedure
|
defined as need for repeat treatment for persistent or recurrent GOO symptoms |
Immediately after the procedure
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Shayan Irani, MBBS, MD, Virginia Mason Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E7152
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .