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

Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195361
• Other study ID #: CD-14-011
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Lyra Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 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 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.

Related Conditions & MeSH terms

• Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
• Prolapse

Intervention

Device:
• SRS - Self Retaining Support system

Locations

Country	Name	City	State
Israel	Mayanei HaYeshua Medical Center	Bnei Brak
Israel	Ziv Medical center	Safed
Israel	Asaf HaRofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in POP-Q points Aa and Ba	Points Aa and\or Ba are less than -1	36 months
Primary	Improvement in POP-Q point C:	Point C at -5 or less	36 months
Primary	No unexpected serious adverse device related events		36 months
Secondary	Achieving normal urinary function:	Patient does not experience voiding dysfunction and have negative Urinary Cough Test.	36 Months
Secondary	Improvement in Quality Of Life (QoL)	Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.	36 Months