Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
Conditions
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
Interventions
DEVICESRS
Sponsors
Lyra Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. 2. Patient age is between 18 and 75 years old 3. POP-Q: Aa and/or Ba is at least -1
Exclusion criteria
1. Patient is pregnant or breastfeeding 2. Patient suffering from active infection (on antibiotic therapy) 3. Patient planning vaginal delivery 4. Patient had Previous vaginal mesh surgery 5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases). 6. 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. 7. Malignancy . 8. Known hypersensitivity to PEEK and polypropylene materials. 9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation. 10. Tendency for hyper-scaring reaction 11. Diagnosed with mental or emotional disturbance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No device related serious adverse events | up to 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications) | up to 12 months |
| Improvement in POP-Q: points Aa and Ba | up to 12 month |
| Improvement in POP-Q point C | up to 12 months |
| Achieving normal urinary function | up to 12 months |
Countries
Hungary, Israel
Outcome results
None listed