GLP Swine Study Clause Samples

GLP Swine Study. ‌ The primary goal of this GLP study was to evaluate the safety and efficacy of the test device (ANET RF applicator) to deliver energy into pseudo-tumors in swine lungs and produce a thermal effect without substantial concurrent damage to the surrounding healthy tissue. This GLP study was conducted under an IACUC approved protocol, SP-1602 GLP: RF Energy Ablation of Lung Pseudotumors Study in Yorkshire-Cross Farm Swine via Bronchoscopy (One Week Evaluation) and in accordance with Spiration’s protocol NCS-05097.AA. The study was conducted at the Care Research and Colorado Histo-Prep facilities in Fort ▇▇▇▇▇▇▇, CO. The protocol was executed without deviations and all amendments to the protocol after the release date were approved in advance by the study director and the sponsor’s representative and handled according to the released SOPs of CARE Research. The test articles were ANET RF Applicator’s produced by Spiration Inc. The test subjects were 6 domestic swine with induced pseudo-tumors in the lungs. A total of 6 pseudo-tumors were ablated, 1 in each swine with 1 pseudo-tumor left un- ablated in the opposite lung as a control. One extra animal was kept in reserve for the duration of the study as a backup. The pseudo-tumors were located and measured by EBUS bronchoscope and one per animal selected for RF ablation using the ANET RF applicator. The amount of energy delivered was based on the depth of the lesion as measured by EBUS, and determined by a predefined algorithm. During the thermal ablation the applicator electrodes are cooled with a flow of sterile physiological saline solution which conducts some of the heat away from the center of the bipolar ablation zone while also helping to maintain conductivity of the ablated tissue. With the rapid cooling of the saline as it expands away from the electrodes, no addition thermal tissue damage can be detected and the saline is absorbed by the tissue vasculature. The ANET applicators all functioned properly, and delivered the pre-determined amount of energy to the target location. Placement, visualization and subsequent removal of the electrodes in the pseudotumor targets was accomplished without complication. After ablations, the swine were recovered and monitored for peri- or post- procedural complications and general health for 7 days, which according to the study pathologist was the optimal time to observe any cytocidal effects in the tissue. Each animal was then euthanized and a gross necropsy performed ...