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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

Sponsor
Lyra Medical Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03195361
Collaborator
(none)
50
Enrollment
3
Locations
1
Arm
57.7
Actual Duration (Months)
16.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: SRS - Self Retaining Support system
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Dec 20, 2020
Actual Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: SRS - Self Retaining Support system
Other Names:
  • transvaginal surgical treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in POP-Q points Aa and Ba [36 months]

      Points Aa and\or Ba are less than -1

    2. Improvement in POP-Q point C: [36 months]

      Point C at -5 or less

    3. No unexpected serious adverse device related events [36 months]

    Secondary Outcome Measures

    1. Achieving normal urinary function: [36 Months]

      Patient does not experience voiding dysfunction and have negative Urinary Cough Test.

    2. Improvement in Quality Of Life (QoL) [36 Months]

      Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayanei HaYeshua Medical Center Bnei Brak Israel 51544
    2 Ziv Medical center Safed Israel
    3 Asaf HaRofeh Medical Center Zrifin Israel 70300

    Sponsors and Collaborators

    • Lyra Medical Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lyra Medical Ltd.
    ClinicalTrials.gov Identifier:
    NCT03195361
    Other Study ID Numbers:
    • CD-14-011
    First Posted:
    Jun 22, 2017
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prolapse

    Study Results

    No Results Posted as of Feb 3, 2021