CompletedNot Applicable

Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Hungary, Israel20 participantsStarted 2014-09

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

No device related serious adverse events

Timeframe: up to 12 month

Trial details

NCT IDNCT02209337

SponsorLyra Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Anterior Vaginal Wall Prolapse trials