NCT03195361CompletedNot 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
Lyra Medical Ltd.5 sites in 1 country50 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- No unexpected serious adverse device related events
Study Overview
Brief 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
Detailed Description
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
No unexpected serious adverse device related events
Time Frame: 36 months
Improvement in POP-Q point C:
Time Frame: 36 months
Point C at -5 or less
Improvement in POP-Q points Aa and Ba
Time Frame: 36 months
Points Aa and\\or Ba are less than -1
Secondary Outcomes
- Achieving normal urinary function:(36 Months)
- Improvement in Quality Of Life (QoL)(36 Months)
Investigators
Study Sites (5)
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