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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRS-I | Experimental | Implantation of SRS-I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| No device related serious adverse events | up to 12 month |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Levi, Dr. | Mayanei HaYeshua Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged | Szeged | Hungary | ||||
| Mayanei HaYeshua Medical Center |
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| Improvement in POP-Q point C | up to 12 months |
| Achieving normal urinary function | up to 12 months |
| Bnei Brak |
| 51544 |
| Israel |
| Asaf HaRofeh Medical Center | Zrifin | 70300 | Israel |