Back to resultsMulticenter, 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
Primary Purpose
Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SRS - Self Retaining Support system
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Eligibility Criteria
Inclusion Criteria:
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
- Patient age is between 50 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is suffering from active infection (on antibiotic therapy)
- Patient is planning vaginal delivery
- Patient had previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).
- 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.
- Malignancy.
- Known hypersensitivity to PEEK and/or polypropylene materials.
- Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- Diagnosed with mental or emotional disturbance.
Sites / Locations
- Mayanei HaYeshua Medical Center
- Ziv Medical center
- Asaf HaRofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-arm
Arm Description
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
Outcomes
Primary Outcome Measures
Improvement in POP-Q points Aa and Ba
Points Aa and\or Ba are less than -1
Improvement in POP-Q point C:
Point C at -5 or less
No unexpected serious adverse device related events
Secondary Outcome Measures
Achieving normal urinary function:
Patient does not experience voiding dysfunction and have negative Urinary Cough Test.
Improvement in Quality Of Life (QoL)
Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195361
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyra Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
Detailed Description
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
SRS - Self Retaining Support system
Other Intervention Name(s)
transvaginal surgical treatment
Primary Outcome Measure Information:
Title
Improvement in POP-Q points Aa and Ba
Description
Points Aa and\or Ba are less than -1
Time Frame
36 months
Title
Improvement in POP-Q point C:
Description
Point C at -5 or less
Time Frame
36 months
Title
No unexpected serious adverse device related events
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Achieving normal urinary function:
Description
Patient does not experience voiding dysfunction and have negative Urinary Cough Test.
Time Frame
36 Months
Title
Improvement in Quality Of Life (QoL)
Description
Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.
Time Frame
36 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
Patient age is between 50 and 75 years old
POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is suffering from active infection (on antibiotic therapy)
Patient is planning vaginal delivery
Patient had previous vaginal mesh surgery
Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).
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.
Malignancy.
Known hypersensitivity to PEEK and/or polypropylene materials.
Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
Diagnosed with mental or emotional disturbance.
Facility Information:
Facility Name
Mayanei HaYeshua Medical Center
City
Bnei Brak
ZIP/Postal Code
51544
Country
Israel
Facility Name
Ziv Medical center
City
Safed
Country
Israel
Facility Name
Asaf HaRofeh Medical Center
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
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
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