Retrospective Analysis of the Safety and Effectiveness of... | NCT02477189

Studies
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

NCT02477189

Sponsor

International Medical Devices, Inc.

Status

Completed

Last Update Posted

Jun 22, 2015Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Penile Implant

Interventions

Silicone Block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

May 15, 2015

First Submission Date that Met QC Criteria

Jun 19, 2015

First Posted Date

Jun 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2015

Last Update Posted Date

Jun 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire.	Procedure: Silicone Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silicone Block	Procedure		Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse Events	Number of adverse events that occurred from implantation through the time of the study.	Up to 4 years, with an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Self-Esteem Score	Evaluation of a self-esteem score done pre-surgery and post-surgery	7 days pre-surgery to 90 days post-surgery
Self-confidence score	Evaluation of a self-confidence score done pre-surgery and post-surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.

Exclusion Criteria:

Medical records for the subject are not available for review or tabulation
Subject did not comply with pre-operative or post-operative instructions.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men age 22 and older who had a penis implant from 2009-2014

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allen Kamrava, MD, MBA		Beverly Hills	California	90211	United States