Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of … (NCT03195361) | Clinical Trial Compass
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
Who can participate
Age range
50 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 50 and 75 years old
. POP-Q: Aa and/or Ba is at least -1
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in POP-Q points Aa and Ba
Timeframe: 36 months
2
Improvement in POP-Q point C:
Timeframe: 36 months
3
No unexpected serious adverse device related events