A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Conditions: Pelvic Organ Prolapse
Sponsor: Allium, Ltd.

 
Post Marketing Surveillance Study - 
Retrospective Study Endofast Reliant SCP Protocol 
Document No. 
CL-SCP-60-04 
Revision 
00 
Page 
1 of  2 
 
 
 
 
 
 
 
 
 
 
 
 
Post Marketing Clinical Follow Up (PMCF) Study  
 
 
A Retrospective Study for collecting data on  
the Safety and Performance of the EndoFast Reliant SCP in 
Vaginal Wall Reinforcement 
Study Protocol 
 
 
 
March 13, 2017 
 
 
 

 
Post Marketing Surveillance Study - 
Retrospective Study Endofast Reliant SCP Protocol 
Document No. 
CL-SCP-60-04 
Revision 
00 
Page 
2 of  2 
 
 
Study Synopsis  
 
Study Design 
A Single arm, single site, retrospective cohort Post 
Marketing Surveillance Study Evaluating the Safety and 
Performance of the EndoFast Reliant SCP for apical 
support 
Study device: 
EndoFast Reliant SCP  
Intended use:  
The EndoFast Reliant SCP is indicated for fixation of 
surgical mesh to tissue for tissue reinforcement during 
laparotomy or laparoscopic Sacrocolpopexy approach. 
Device Regulatory 
status: 
CE, AMAR and FDA Approval  
Objective: 
The objective of this study is to collect data on the 
anatomical cure and safety of the EndoFast Reliant SCP  
Medical Centers  
One site in Germany Catholic Hospital Hoxter, Germany 
Dr. Bettin 
 
Population:   
Female subjects >18 years old that underwent Pelvic 
Organ Prolapse repair utilizing the EndoFast Reliant  SCP 
Procedure: 
 
Pelvic Organ Prolapse repair utilizing the EndoFast Reliant  
SCP  
Follow-up:  
 
Upon availability of the data (retrospective study) 
Safety Endpoint:  
 
The safety endpoint counts the rate of peri and post-
operative device related Adverse Events. 
Effectiveness 
Endpoints:  
measures the relative improvement in Pelvic Organ 
Prolapse staging using the POPQ grading system  
Inclusion criteria 
All Female subjects >18 years old that underwent Pelvic 
Organ Prolapse repair utilizing the EndoFast Reliant  SCP 
Exclusion criteria 
Patients without follow-up 
 
Sponsor:  
IBI, Israel Biomedical Innovations Ltd. 
2 Ha-Eshel St., P.O.BOX 3081, Caesarea Industrial Park, 
3088900 - Israel 
Tel: +972-4-6277166  
Fax: +972-4-6277266