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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anterior Vaginal Wall Prolapse Vaginal Apex/Uterine Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SRS-I

Implantation of SRS-I

Group Type EXPERIMENTAL

SRS

Intervention Type DEVICE

Interventions

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SRS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
2. Patient age is between 18 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria

1. Patient is pregnant or breastfeeding
2. Patient suffering from active infection (on antibiotic therapy)
3. Patient planning vaginal delivery
4. Patient had Previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
6. 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.
7. Malignancy .
8. Known hypersensitivity to PEEK and polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Tendency for hyper-scaring reaction
11. Diagnosed with mental or emotional disturbance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No