Ocean Springs

Researchers are conducting a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in adults diagnosed with Acute Respiratory Distress Syndrome ARDS. The study is randomized, double-blind, and placebo-controlled with dose escalation to assess how the drug behaves in the body and its effects compared to placebo. An independent Safety Review Committee will monitor data throughout the study to ensure participant safety. Participants will receive GEn-1124 or placebo as a 2-hour intravenous infusion as soon as possible after ARDS diagnosis. A second dose will be given about 8 hours after the first, followed by twice daily dosing for five days. The study includes low and high dose groups in the first part and additional dosing in the second part depending on earlier results. During the study, participants will be closely monitored for safety and tolerability for up to 60 days after the first dose or until death if earlier. Researchers will assess serious adverse events and other side effects. The study involves multiple visits for treatment and follow-up, with data collected on how participants respond to the drug over time.

Researchers are evaluating the safety, effectiveness, and tolerability of the NOVOCLEAR174 Device used with the AVENTIX174 PFX System for treating chronic rhinitis. This condition involves persistent nasal symptoms, and the study aims to understand how this radiofrequency-based pulsed field energy device affects the soft tissues in the nasal airway, including the posterior nasal nerve region. The study is a non-significant risk, prospective, multi-center, single arm trial supported by Aventix Medical Inc. The treatment involves applying pulsed field energy through the NOVOCLEAR174 Device to the nasal tissues, targeting the posterior nasal nerve area. This device works with the AVENTIX174 PFX System, which delivers non-thermal pulsed field energy. All participants receive this intervention during the study period there is no comparison group. Participants will be involved for at least 90 days, with assessments at 7, 14, 30, 90 days, 6 months, and 1 year after treatment. Researchers will measure changes in nasal symptoms using the Reflective Total Nasal Symptom Score rTNSS, procedure tolerability, and participant satisfaction. Safety is monitored through the occurrence of serious device or procedure-related adverse events. The study includes written consent and protocol compliance, with ongoing follow-up for up to one year.