Status:
COMPLETED
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Lead Sponsor:
Lyra Medical Ltd.
Conditions:
Anterior Vaginal Wall Prolapse
Vaginal Apex/Uterine Prolapse
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
Eligibility Criteria
Inclusion
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
- Patient age is between 18 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Exclusion
- Patient is pregnant or breastfeeding
- Patient suffering from active infection (on antibiotic therapy)
- Patient planning vaginal delivery
- Patient had Previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
- Malignancy .
- Known hypersensitivity to PEEK and polypropylene materials.
- Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- Tendency for hyper-scaring reaction
- Diagnosed with mental or emotional disturbance.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02209337
Start Date
September 1 2014
End Date
March 1 2018
Last Update
August 16 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Szeged
Szeged, Hungary
2
Mayanei HaYeshua Medical Center
Bnei Brak, Israel, 51544
3
Asaf HaRofeh Medical Center
Zrifin, Israel, 70300