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

Not Applicable

Completed

• Conditions: Anterior Vaginal Wall Prolapse; Vaginal Apex/Uterine Prolapse
• Interventions: Device: SRS

• Registration Number: NCT02209337
• Lead Sponsor: Lyra Medical Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-03
• Study First Submitted QC: 2014-08-03
• Study First Posted: 2014-08-05
• Study Start: 2014-09
• Primary Completion: 2016-03
• Study Completion: 2018-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SRS-I	SRS	Implantation of SRS-I

Primary Outcome Measures

Name	Time	Method
No device related serious adverse events	up to 12 month

Secondary Outcome Measures

Name	Time	Method
Achieving normal urinary function	up to 12 months
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

Trial Locations

Locations (3)

University of Szeged; 🇭🇺 Szeged, Hungary

Mayanei HaYeshua Medical Center; 🇮🇱 Bnei Brak, Israel

Asaf HaRofeh Medical Center; 🇮🇱 Zrifin, Israel