General Description of Study Sample Clauses

General Description of Study. ‌ After consent and evaluation of all inclusion and exclusion criteria, subjects will be enrolled in the study. The subject will undergo standard pre-operative testing, per the study institutional requirements. At that time, subject xxxxx xxxxx will be recorded. The subject will be prepped for bronchoscopy. A pre-ablation chest CT will be taken. The target nodule/tumor will be accessed via EBUS bronchoscopy, which may be guided and confirmed with Cone Beam CT, Intra-operative CT, or fluoroscopy, and ablated using the ANET Electrosurgical Applicator. Following ablation, there will be a bronchoscopic exam of the treated region and repeat chest CT will be taken. Immediately following bronchoscopy and ablation of the target tissue, the subject will undergo the planned surgical resection. The ablated tumor will be prepared for histopathological and immuno-histochemistry evaluation to assess the area of ablated tissue. Subjects will be followed peri-operatively. There is no long-term follow-up since the ablated tissue will be resected during the surgical procedure, however adverse events will be captured through 30 days post procedure. Blood will be drawn pre and post-ablation and 2-4 weeks post-surgery, per the ANET Blood Draw Lab Manual, DN0042775, to evaluate for potential immune response indicators. Blood specimens will be analyzed by a core laboratory to characterize cells important in immune responses and the disease process. A study diagram is shown in Figure 4 below.
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General Description of Study. ‌ After consent and evaluation of all inclusion and exclusion criteria, subjects will be enrolled in the study. The subject will undergo standard pre-operative testing, per the study institutional requirements. At that time, subject xxxxx xxxxx will be recorded. The subject will be prepped for bronchoscopy. A pre-ablation chest CT will be taken. The target nodule/tumor will be accessed via EBUS bronchoscopy and ablated using the ANET Electrosurgical Applicator. Following ablation, there will be a bronchoscopic exam of the treated region and a repeat chest CT will be taken. Immediately following bronchoscopy and ablation of the target tissue, the subject will undergo the planned surgical resection. The ablated tumor will be prepared for histopathological and may be prepared for immunohistochemistry evaluation to assess the area of ablated tissue. Subjects will be followed peri-operatively. There is no long-term follow-up since the ablated tissue will be resected during the surgical procedure, however adverse events will be captured through 30 days post procedure. Blood will be drawn pre and post-ablation and 2-4 weeks post-surgery to evaluate for potential immune response indicators. A study diagram is shown in Figure 4 below. 6 SUBJECT POPULATION‌ Adult subjects with confirmed Stage I or Stage II primary lung cancer or metastatic lung tumor with a pulmonary nodule/tumor suitable for ablation, by the ANET device via EBUS bronchoscopy, prior to planned surgical resection.

Related to General Description of Study

  • General Description Employer shall provide Employee with the compensation, incentives, benefits, and business expense reimbursement specified elsewhere in this agreement.

  • General Description of Services The A-E will be contacted by COUNTY Project Management staff on an “as-needed” basis as projects arise to provide A-E for professional services. Requirements will be discussed by both Parties and A-E shall prepare a written Scope Statement that will include the specific work to be performed, including the costs and time required to complete the project/task. Orange COUNTY Project Management staff will then review the A-E’s Scope Statement, proceed with negotiation of task costs and when satisfied, issue a Contract Task Order (CTO) against this CONTRACT. The A-E shall serve as lead of a design team that may include other construction design professionals working together to ensure that the original design is carried through to the finished product, with no alterations in materials or design that would lead to safety issues or compromise the quality of the building or building component. Other team members who may be retained by the lead to support a project as a consultant may include but are not limited to landscape architects, lighting designers, data consultants, security consultants, controls engineers, commissioning consultants, traffic engineers, surveyors, estimators, special inspection, etc. The A-E shall be responsible for the preparation of comprehensive building assessments, designs, drawings, specifications, cost estimates, and reports within the scope of the Contract Task Order (CTO). In the preparation of construction drawings and specification, the A-E shall also responsible for:

  • General Description of Work The work under this AGREEMENT shall consist of the above-described SERVICES as herein defined, and necessary to accomplish the completed work for this project. The CONSULTANT shall furnish all services, labor, and related equipment and, if applicable, sub-consultants and subcontractors necessary to conduct and complete the SERVICES as designated elsewhere in this AGREEMENT.

  • General Description of Land Use 3.3.1 The use(s) of the Lands permitted by this Agreement are the following:

  • GENERAL DESCRIPTION AND LIMITATIONS Competitive Supplier is hereby granted the exclusive right to provide All-Requirements Power Supply to Participating Consumers pursuant to the terms of the Program and this ESA. For the avoidance of doubt, Competitive Supplier shall be authorized to supply All-Requirements Power Supply only to Participating Consumers, and the Local Distributor will continue to have the right and obligation to supply electricity to Eligible Consumers who opt-out of the Program and remain on, or return to, Basic Service, until changes in law, regulation or policy may allow otherwise. Competitive Supplier further recognizes that this ESA does not guarantee that any individual Eligible Consumer will be served by the Competitive Supplier. In accordance with Article 3 below, all Eligible Consumers shall be automatically enrolled in the Program unless they choose to opt-out. In the event the geographic boundaries of the Town change during the term of this ESA, Competitive Supplier shall only be obligated to supply All- Requirements Service to those Participating Consumers located within the Town as such boundaries existed on the Effective Date of this ESA. As between the Parties, the Competitive Supplier has the sole obligation of making appropriate arrangements with the Local Distributor, and any arrangements which may be necessary with the ISO-NE so that Participating Consumers receive the electricity supplies to be delivered pursuant to this ESA. The Town shall specifically authorize the Local Distributor to provide, and Competitive Supplier the right to obtain and utilize as required, all billing and energy consumption information for Participating Consumers as is reasonably available from the Local Distributor. Competitive Supplier shall request consumption data for individual Participating Consumers from the Local Distributor via EDI. If further action is required by the Local Distributor to authorize Competitive Supplier to receive such consumption and billing data, the Town agrees to use Commercially Reasonable efforts, at Competitive Supplier’s cost, to assist Competitive Supplier, if so requested by it, in obtaining such information for Participating Consumers, including, without limitation, assisting Competitive Supplier in obtaining permission from such Eligible Consumers and/or the Department, where necessary as a prerequisite to the provision of such information. Competitive Supplier shall not be responsible for any errors that Competitive Supplier makes in the provision of All-Requirements Power Supply to the extent such errors are caused by errors or omissions in the information provided to it by the Local Distributor.

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  • Task Description This task includes activities associated with permit-required monitoring conducted in accordance with the conditions specified by state or federal regulatory agencies. All monitoring tasks must be located within or adjacent to the Project area and follow the Department’s Regional Coastal Monitoring Program and FWC's marine turtle and shorebird monitoring programs. Guidance for monitoring of nearshore resources is available in the Department's Standard Operation Procedures For Nearshore Hardbottom Monitoring Of Beach Nourishment Projects. The Local Sponsor must submit work products directly to the appropriate state or federal regulatory agencies in accordance with permit conditions to be eligible for reimbursement under this task, unless otherwise directed.

  • Description of Benefits The benefits available under this Plan will be as defined in Item F(5) of the Adoption Agreement.

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  • Description of Program This Agreement is established to facilitate an exchange program at the partner institution with students, faculty and researchers from each institution (collectively, the “Exchange Program”). The student exchange program enables students from one university to take classes at the other university while working towards a degree at the university where he or she is formally enrolled (individually, the “Student Exchange”) and to encourage faculty members and researchers from each university to visit the other university and engage in certain activities (individually, the “Faculty/Researcher Exchange”). [Substitute the purpose of your program if different.] For purposes of this Agreement, with respect to the Student Exchange, the term “Home University” shall mean the institution in which a student is formally enrolled as a degree candidate, and “Host University” shall mean the institution that has agreed to receive students from the Home University for a period of study. With respect to the Faculty/Researcher Exchange, as used herein, “Home University” shall mean the university where the faculty member and/or researcher is normally employed, and “Host University” shall mean the university that the faculty member and/or researcher is visiting.

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