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

Anterior Vaginal Wall Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209337
• Other study ID #: CD-14-005
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2019
• Source: Lyra Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Vaginal Wall Prolapse
• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse
• Vaginal Apex/Uterine Prolapse

Intervention

Device:
• SRS

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged
Israel	Mayanei HaYeshua Medical Center	Bnei Brak
Israel	Asaf HaRofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Medical Ltd.

Countries where clinical trial is conducted

Hungary,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No device related serious adverse events		up to 12 month
Secondary	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
Secondary	Improvement in POP-Q: points Aa and Ba		up to 12 month
Secondary	Improvement in POP-Q point C		up to 12 months
Secondary	Achieving normal urinary function		up to 12 months