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

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-12-20

Brief Summary

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

Conditions

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Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent

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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Single-arm

Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device

Group Type EXPERIMENTAL

SRS - Self Retaining Support system

Intervention Type DEVICE

Interventions

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SRS - Self Retaining Support system

Intervention Type DEVICE

Other Intervention Names

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transvaginal surgical treatment

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 50 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 is suffering from active infection (on antibiotic therapy)
3. Patient is 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, coagulatory 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/or polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Diagnosed with mental or emotional disturbance.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No