CompletedNot Applicable

Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Israel50 participantsStarted 2016-03

Plain-language summary

A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Age range50 Years – 75 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
✓. Patient age is between 50 and 75 years old
✓. POP-Q: Aa and/or Ba is at least -1

✕. Patient is pregnant or breastfeeding
✕. Patient is suffering from active infection (on antibiotic therapy)
✕. Patient is planning vaginal delivery
✕. Patient had previous vaginal mesh surgery
✕. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory 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/or polypropylene materials.

Improvement in POP-Q points Aa and Ba

Timeframe: 36 months

Improvement in POP-Q point C:

Timeframe: 36 months

No unexpected serious adverse device related events

Timeframe: 36 months

NCT IDNCT03195361

SponsorLyra Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-20