10 results
The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is…
The primary objective of this study is to determine the safety and feasibility of fluorescence molecular endoscopy using the fluorescent tracer bevacizumab-800CW for identification of pathological complete response after neoadjuvant…
Phase 1 (0 - 24 Weeks) Objective:To study the effect of DMR on glycemic and mechanistic endpoints24 weeks post-procedure in subjects with T2D.Phase 2 (24 - 48 Weeks) Objective:To study the effect of DMR on glycemic endpoints for assessment…
To evaluate the feasibility, safety and efficacy related endpoints for the Fractyl Revita System for the treatment of uncontrolled type 2 diabetes.
Primary objective: - To determine the feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to identify dysplasia and/or malignant lesions in patients with Barrett*s esophagus. - To evaluate the safety of EMI-…
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get insight in the PD-L1 expression before and after neoadjuvant therapy in…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…
Primary:To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in…