Penile Length Maintenance Post-Prostatectomy NCT# 03500419 July 3, 2019
Penile Length Maintenance Post-Prostatectomy
NCT# 03500419
July 3, 2019
IRB: 18-001013
Version 6.0 Revised 7/3/2019
PENILE LENGTH MAINTENANCE POST-PROSTATECTOMY
Principal Investigator [Co-Investigator(s)]
Funding Sponsor: Study Product:
Matthew Ziegelmann, MD
Landon Trost, MD Tobias Kohler, MD Josh Savage, PA-C Elise Tentis, PA-C Steve Carlson, APRN, CNP
Mayo Clinic
RestoreX?
Protocol Number: (IRBe)
Initial version: January 31, 2018 Version (1.0) Revised version: April 5, 2018 Version (2.0)
May 4, 2018 Version (3.0) November 20, 2018 Version (4.0) April 23, 2019 Version (5.0) July 3, 2019 Version (6.0)
Page 1 of 19 Dr. Ziegelmann
IRB: 18-001013
Version 6.0 Revised 7/3/2019
Table of Contents
STUDY SUMMARY ................................................................................................................................5
1 INTRODUCTION...........................................................................................................................6
1.1 BACKGROUND............................................................................................................................................. 6
1.2 INVESTIGATIONAL DEVICE.......................................................................................................................... 6
1.3 PRELIMINARY DATA ................................................................................................................................... 7
1.4
STUDY RATIONALE AND RISK ANALYSIS (RISKS TO BENEFITS RATIO)....................................................... 7
1.4.1 Study Rationale....................................................................................................................7
1.4.2 Potential Benefits.................................................................................................................7
1.5
ANTICIPATED DURATION OF THE CLINICAL INVESTIGATION....................................................................... 8
2 STUDY OBJECTIVES....................................................................................................................8
2.1 PRIMARY OBJECTIVE .................................................................................................................................. 8 2.2 SECONDARY OBJECTIVE ............................................................................................................................. 8
3 STUDY DESIGN.............................................................................................................................8
3.1 SUBJECT SELECTION ................................................................................................................................... 9 3.1.1 Inclusion Criteria.................................................................................................................9 3.1.2 Exclusion Criteria ................................................................................................................9
3.2 SETTING ...................................................................................................................................................... 9 3.3 RECRUITMENT............................................................................................................................................. 9 3.4 CONSENT AND ENROLLMENT ...................................................................................................................... 9 3.5 STUDY SCHEMA ........................................................................................................................................ 10 3.6 RANDOMIZATION PROTOCOL .................................................................................................................... 11
4 STUDY PROCEDURES............................................................................................................... 11
4.1 PRE-OPERATIVE ASSESSMENTS ................................................................................................................ 11 4.2 BASELINE ASSESSMENT ............................................................................................................................ 11 4.3 6 MONTH VISIT ......................................................................................................................................... 12 4.4 9 MONTH VISIT ......................................................................................................................................... 12 4.5 ASSESSMENT OF LENGTH .......................................................................................................................... 12 4.6 SCHEDULE OF EVENTS .............................................................................................................................. 12
5 STATISTICAL PLAN.................................................................................................................. 13
5.1 DATA HANDLING ...................................................................................................................................... 13 5.2 STATISTICAL ANALYSIS ............................................................................................................................ 13
6 SAFETY AND ADVERSE EVENTS ............................................................................................ 14
6.1 ADVERSE EVENT REPORTING PERIOD ....................................................................................................... 15
6.2 PREEXISTING CONDITION.......................................................................................................................... 15
6.3 POST-STUDY ADVERSE EVENT.................................................................................................................. 15
6.4
HOSPITALIZATION, PROLONGED HOSPITALIZATION OR SURGERY............................................................. 15
6.5 RECORDING OF ADVERSE EVENTS ............................................................................................................ 15
6.6
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS.......................................... 16
6.6.1 Sponsor-investigator Reporting: Notifying the Mayo IRB ..................................................... 16
6.6.2 Stopping Rules.................................................................................................................. 16
6.6.3 Medical Monitoring .......................................................................................................... 17
7 DATA HANDLING AND RECORD KEEPING........................................................................... 17
7.1 CONFIDENTIALITY..................................................................................................................................... 17 7.2 SOURCE DOCUMENTS................................................................................................................................ 17 7.3 RECORDS RETENTION ............................................................................................................................... 17
8 STUDY FINANCES ..................................................................................................................... 18
Page 2 of 19 Dr. Ziegelmann
IRB: 18-001013
Version 6.0 Revised 7/3/2019
8.1 FUNDING SOURCE ..................................................................................................................................... 18 8.2 CONFLICT OF INTEREST............................................................................................................................. 18 8.3 SUBJECT STIPENDS OR PAYMENTS ............................................................................................................ 18 8.4 REGULATORY INFORMATION .................................................................................................................... 18
9 REFERENCES ............................................................................................................................ 19
Page 3 of 19 Dr. Ziegelmann
IRB: 18-001013
AE HIPAA PTT PD RCT
Version 6.0 Revised 7/3/2019
LIST OF ABBREVIATIONS
Adverse Event/Adverse Experience Health Insurance Portability and Accountability Act Penile traction therapy Peyronie's Disease Randomized controlled trial
Page 4 of 19 Dr. Ziegelmann
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