5 results
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections (right hemicolectomy, left hemicolectomy/sigmoid resection), anti-reflux/hiatal hernia…
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in the following laparoscopic procedures: hernia repair, cholecystectomy, right colectomy, Nissen fundoplication and sigmoidresection. The AutoLap…
Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System:
RELAX-OAB
The RELAX-OAB is a post-market clinical follow-up (PMCF) study designed to confirm the safety and technical performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB). The…