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Phase 2-4 Protocol Template

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Phase 2-4 Protocol Template PROTOCOL A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery (NCT01728844) Sponsor: Sunstar Americas, Inc. 1300 Abbott Drive Elgin, IL 60123 Study Number: CLP-2011-10-31-1 IDE Number: G110210 Device: GUIDOR® Growth Factor Enhanced Bone Graft Substitute Date: Feb 20, 2013 Protocol Revision: Effective Date Version Description of Change Oct. 31, 2011 1 New Jul. 24, 2012 2 Amendment Feb. 20, 2013 3 Amendment CONFIDENTIAL PROPERTY OF SUNSTAR AMERICAS, INC. This document is a confidential communication of Sunstar Americas, Inc. Acceptance of this document constitutes the agreement by the recipient that no information contained herein will be published or disclosed without written authorization from Sunstar Americas, Inc. except to the extent necessary to obtain informed consent from those persons to whom the device may be administered. Furthermore, the information is only meant for review and compliance by the recipient, his or her staff, and applicable institutional review committee and regulatory agencies to enable conduct of the study. Study No. CLP 2011-10-31-1 Ver. 3 Page 2 of 68 Protocol 20 February 2013 TABLE OF CONTENTS 1.0 STUDY SUMMARY ...................................................................................................... 6 2.0 STUDY REFERENCE INFORMATION ........................................................................ 9 2.1 Study-Related Responsibilities ................................................................................... 9 2.2 Lead Principal Investigator ...................................................................................... 11 2.3 List of Abbreviations ............................................................................................... 12 3.0 INTRODUCTION ......................................................................................................... 13 3.1 Background ............................................................................................................. 13 3.1.1 Investigational Device ........................................................................................ 13 3.1.2 -TCP ................................................................................................................ 13 3.1.3 Rh-bFGF ............................................................................................................ 13 3.2 Proposed Intended Use ............................................................................................ 14 3.3 Scientific Rationale for the Proposed Study ............................................................. 14 3.4 Mode of Action ........................................................................................................ 15 3.5 Potential Risks ......................................................................................................... 15 3.5.1 Potential Risks Associated With The Procedure ................................................. 15 3.5.2 Potential Risks Associated With β-TCP ............................................................. 16 3.5.3 Potential Risks Associated With rh-bFGF in GFeBGS ....................................... 16 4.0 STUDY OBJECTIVES AND ENDPOINTS .................................................................. 18 4.1 Objectives ................................................................................................................ 18 4.1.1 Primary Objective: ............................................................................................. 18 4.1.2 Secondary Objective: ......................................................................................... 18 4.2 Endpoints................................................................................................................. 18 4.2.1 Primary Effectiveness Endpoint ......................................................................... 18 4.2.2 Secondary Effectiveness Endpoints .................................................................... 18 4.2.3 Safety Endpoints ................................................................................................ 19 5.0 STUDY DESIGN AND DESCRIPTION ....................................................................... 20 5.1 Study Design ........................................................................................................... 20 5.2 Justification for Study Design and Endpoints ........................................................... 21 5.2.1 Study Design...................................................................................................... 21 5.2.2 Primary Effectiveness Endpoint ......................................................................... 21 5.2.3 Secondary Effectiveness Endpoints .................................................................... 22 5.2.4 Safety Endpoints ................................................................................................ 24 5.3 Premature Termination or Suspension of Study or Investigational Site ..................... 24 CONFIDENTIAL Study No. CLP 2011-10-31-1 Ver. 3 Page 3 of 68 Protocol 20 February 2013 5.3.1 Criteria for Premature Termination or Suspension of the Study .......................... 24 5.3.2 Criteria for Premature Termination or Suspension of Investigational Sites ......... 24 5.3.3 Procedures for Premature Termination or Suspension of the Study or the Participation of Investigational Site(s) ................................................................ 24 6.0 SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS .............. 26 6.1 Inclusion Criteria ..................................................................................................... 26 6.2 Exclusion Criteria .................................................................................................... 26 6.3 Excluded Medications and Treatments ..................................................................... 27 6.3.1 Excluded Medications ........................................................................................ 27 6.3.2 Excluded Treatment ........................................................................................... 28 6.4 Criteria of Failures (Discontinuation or Withdrawal of a Subject) .............................. 28 6.5 Procedures for Discontinuation or Withdrawal of a Subject...................................... 29 7.0 INVESTIGATIONAL DEVICE DESCRIPTION .......................................................... 30 7.1 Investigational Device ............................................................................................. 30 7.1.1 Manufacturing, Packaging, and Labeling ........................................................... 30 7.1.2 Storage ............................................................................................................... 31 7.2 Randomization Code Creation and Storage .............................................................. 31 7.3 Investigational Device Blind Maintenance ............................................................... 32 7.4 Unblinding Procedure .............................................................................................. 32 7.5 Accountability and Return of Investigational Device................................................ 32 8.0 STUDY PLAN .............................................................................................................. 34 8.1 Study Procedures ..................................................................................................... 34 8.1.1 Informed Consent Procedure .............................................................................. 34 8.1.2 Clinical Outcomes .............................................................................................. 34 8.1.3 Radiologic Outcomes ......................................................................................... 35 8.1.4 Procedures for Clinical Laboratory Samples ....................................................... 38 8.1.5 Pregnancy .......................................................................................................... 38 8.1.6 Documentation of Screening Failure .................................................................. 38 8.2 Examiner Calibration ............................................................................................... 39 8.2.1 Training of Surgeons, and Training of Examiners .............................................. 39 8.2.2 Intra-Examiner Reproducibility .......................................................................... 39 8.2.3 Radiographic Quality Assurance and Calibration ............................................... 39 8.3 Schedule of Observations and Procedures ................................................................ 39 8.3.1 Visit 1: Screening ............................................................................................... 39 CONFIDENTIAL Study No. CLP 2011-10-31-1 Ver. 3 Page 4 of 68 Protocol 20 February 2013 8.3.2 Visits 2 and 3: Pre-Treatment Procedures ........................................................... 41 8.3.3 Visit 4: Baseline Examination ............................................................................ 41 8.3.4 Visit 5: Periodontal Surgery and Implantation of Investigational Device ............ 42 8.3.5 Visits 6 and 7: Follow-up Evaluations ...............................................................
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