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

Lyra Medical Ltd.3 sites in 1 country50 target enrollmentMarch 2016

Overview

Phase: N/A
Intervention: Not specified
Conditions: Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Sponsor: Lyra Medical Ltd.
Enrollment: 50
Locations: 3
Primary Endpoint: No unexpected serious adverse device related events
Status: Completed
Last Updated: 5 years ago

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

The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

December 20, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

Lyra Medical Ltd.

Responsible Party

Sponsor

•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.
•Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
•Diagnosed with mental or emotional disturbance.