Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00636506
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2008-03-11
Brief Title:
Evaluation of the 2005 AMS American Medical System IPP Inflatable Penile Prosthesis
Sponsor:
American Medical Systems
Organization:
American Medical Systems
Study Overview
Official Title:
A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders Pump and Reservoir
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate modifications to the AMS 700 Series pump cylinders reservoir and rear tip extender design their impact on ease of use for the patient and ease of implantation for the physician
Detailed Description:
Erectile dysfunction the inability to attain or sustain a penile erection sufficient to permit satisfactory sexual intercourse affects an estimated ten to 30 million men in the United States Erectile dysfunction can be caused by many organic abnormalities including diabetes mellitus hypertension vascular disease neurogenic disorders and other chronic diseases Erectile dysfunction can be effectively treated with a variety of methods including the implantation of an inflatable penile prosthesis A multi-center trial is to be conducted to assess the AMS IPP 2002 Inflatable Penile Prosthesis including handling during IPP implantation procedures and short-term follow-up experience of subjects The study will collect pre-operative information comparing the pump operation using scrotal models of the current pump with the study pump and baseline erectile function history Surgical data will be collected to assess device design and procedure enhancements Patient and physician assessment of study device function ease of use ease of traininglearning and adverse events will be gathered post-operatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None