drugset / Trial / NCT06533527

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

NCT06533527

Phase 4 Completed 69 enrolled The Cleveland Clinic
RandomizedParallel-groupDouble-blindHealth-services research

Summary

To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV). Primary Outcomes: * Residual gastric volume that precludes adequate endoscopic examination * Residual gastric volume that necessitates premature termination of the endoscopy procedure * Need for endotracheal intubation due to stomach contents. * Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission Secondary Outcomes: * Presence of any solid food * Presence of moderate liquid content * Increased RGV(Residual Gastric Volume) defined as any amount of solid content or \> 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister). * Differences in primary and secondary outcomes between different medications

Timeline

Start
2024-07-31
Primary completion
2025-05-20
Completion
2025-05-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dulaglutide Peptide
Comparator Liraglutide Peptide
Comparator Semaglutide Peptide
Comparator Tirzepatide Peptide