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

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

Study Overview

• Status: Completed
• Conditions: Anterior Vaginal Wall Prolapse; Vaginal Apex/Uterine Prolapse
• Intervention / Treatment: Device: SRS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary
    • University of Szeged
• Israel
  • Bnei Brak, Israel, 51544
    • Mayanei HaYeshua Medical Center
  • Zrifin, Israel, 70300
    • Asaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRS-I; Implantation of SRS-I	Device: SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No device related serious adverse events	up to 12 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)	up to 12 months
Improvement in POP-Q: points Aa and Ba	up to 12 month
Improvement in POP-Q point C	up to 12 months
Achieving normal urinary function	up to 12 months

Collaborators and Investigators

• Sponsor: Lyra Medical Ltd.
• Investigators: Principal Investigator: Gil Levi, Dr., Mayanei HaYeshua Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 3, 2014
• First Submitted That Met QC Criteria: August 3, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Uterine Prolapse
• Other Study ID Numbers: CD-14-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No