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Latera® Absorbable Nasal Implant Vs. Sham Control for Lateral Nasal Valve Collapse

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Latera® Absorbable Nasal Implant Vs. Sham Control for Lateral Nasal Valve Collapse Latera RCT – Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse Device: Latera™ Protocol Number: CP04 Version: 3.0 23 March 2018 Sponsor Spirox, Inc. 595 Penobscot Drive Redwood City, CA 94063 USA CONFIDENTIALITY STATEMENT This Clinical Investigation Plan and all attachments are considered confidential information. The contents must not be disclosed, unless authorized in writing by Spirox, Inc., except that this document may be disclosed to the appropriate Institutional Review Board (IRB) or duly authorized representative of the U.S. Food and Drug Administration (FDA) with similar requests for maintenance of confidentiality. All data and study results are similarly subjected to the same disclosure restrictions as the investigational plan, as stated above. All copies of this investigational device exemption remain the property of Spirox, Inc. Spirox, Inc. Version 3.0 LATERA RCT 23 March 2018 TABLE OF CONTENTS Table of Contents ........................................................................................................................................ 2 Summary of Changes .................................................................................................................................. 6 Statement of Compliance ........................................................................................................................... 7 Investigator Signature Page ....................................................................................................................... 8 Synopsis ........................................................................................................................................................ 9 1. Introduction ....................................................................................................................................... 14 1.1. Background on Nasal Valve Collapse ........................................................................................... 14 1.2. Prior Investigations ........................................................................................................................ 14 1.3. Current Study: The Latera Randomized Controlled Trial.............................................................. 17 2. Study Device ...................................................................................................................................... 17 2.1. Indication for Use .......................................................................................................................... 18 2.2. Manufacturer and Study Sponsor ................................................................................................... 18 2.3. Clearance Status ............................................................................................................................. 18 2.4. Model Numbers ............................................................................................................................. 18 2.5. Device Description......................................................................................................................... 18 3. Study Objectives and Endpoints ...................................................................................................... 20 3.1. Study Objectives ............................................................................................................................ 20 3.2. Primary Endpoint ........................................................................................................................... 20 3.3. Secondary Endpoints ..................................................................................................................... 20 4. Study Population ............................................................................................................................... 20 4.1. Patient Eligibility ........................................................................................................................... 21 4.2. Patient Screening and Informed Consent ....................................................................................... 22 4.3. Subject Disposition and Flow Chart .............................................................................................. 22 4.4. Withdrawals and Loss to Follow-up .............................................................................................. 23 5. Study Procedures and Follow-up Evaluations................................................................................ 24 5.1. Screening/Baseline Assessment ..................................................................................................... 24 5.2. Treatment Visit .............................................................................................................................. 25 5.3. Follow-Up Assessments................................................................................................................. 28 5.4. Retrievals and Re-Implantation ..................................................................................................... 31 LATERA RCT Page 2 CONFIDENTIAL Spirox, Inc. Version 3.0 LATERA RCT 23 March 2018 6. Statistics and Data Analysis ............................................................................................................. 32 6.1. Hypothesis ..................................................................................................................................... 32 6.2. Study Populations .......................................................................................................................... 32 6.3. Unblinding and Crossover Subjects ............................................................................................... 33 6.4. Sample Size .................................................................................................................................... 33 6.5. Missing Data .................................................................................................................................. 33 6.6. Demographics and Baseline Characteristics .................................................................................. 34 6.7. Changes to Planned Analyses ........................................................................................................ 34 6.8. Interim Analyses ............................................................................................................................ 34 7. Study Management Considerations ................................................................................................. 34 7.1. Data Management: Collection of Clinical Data ............................................................................. 34 7.2. Protocol Amendments .................................................................................................................... 35 7.3. Protocol Deviations ........................................................................................................................ 35 7.4. Information to Study Personnel ..................................................................................................... 35 8. Risk-Benefit Analysis ........................................................................................................................ 35 8.1. Risks to the Subjects ...................................................................................................................... 35 8.2. Risk Mitigation .............................................................................................................................. 37 8.3. Benefit to Subjects ......................................................................................................................... 37 8.4. Study Justification .......................................................................................................................... 37 9. Assessments of Safety ........................................................................................................................ 38 9.1. Defining Adverse Events ............................................................................................................... 38 9.2. Reporting of Adverse Events ......................................................................................................... 39 9.3. Medical Monitor ............................................................................................................................ 39 9.4. Data Monitoring Committee .......................................................................................................... 40 10. Study Administration........................................................................................................................ 40 10.1. Site Initiation and Study Monitoring ............................................................................................. 40 10.2. Study Termination ......................................................................................................................... 40 10.3. Data Handling and Recordkeeping ................................................................................................ 40 11. Ethics .................................................................................................................................................. 41 11.1. Informed Consent .........................................................................................................................
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