Back to resultsDemonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Primary Purpose
Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SRS
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Vaginal Wall Prolapse
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 18 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient suffering from active infection (on antibiotic therapy)
- Patient planning vaginal delivery
- Patient had Previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic 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 polypropylene materials.
- Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- Tendency for hyper-scaring reaction
- Diagnosed with mental or emotional disturbance.
Sites / Locations
- University of Szeged
- Mayanei HaYeshua Medical Center
- Asaf HaRofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SRS-I
Arm Description
Implantation of SRS-I
Outcomes
Primary Outcome Measures
No device related serious adverse events
Secondary Outcome Measures
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)
Improvement in POP-Q: points Aa and Ba
Improvement in POP-Q point C
Achieving normal urinary function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209337
Brief Title
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Official Title
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2018 (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, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRS-I
Arm Type
Experimental
Arm Description
Implantation of SRS-I
Intervention Type
Device
Intervention Name(s)
SRS
Primary Outcome Measure Information:
Title
No device related serious adverse events
Time Frame
up to 12 month
Secondary Outcome Measure Information:
Title
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)
Time Frame
up to 12 months
Title
Improvement in POP-Q: points Aa and Ba
Time Frame
up to 12 month
Title
Improvement in POP-Q point C
Time Frame
up to 12 months
Title
Achieving normal urinary function
Time Frame
up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 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 18 and 75 years old
POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient suffering from active infection (on antibiotic therapy)
Patient planning vaginal delivery
Patient had Previous vaginal mesh surgery
Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic 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 polypropylene materials.
Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
Tendency for hyper-scaring reaction
Diagnosed with mental or emotional disturbance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Levi, Dr.
Organizational Affiliation
Mayanei HaYeshua Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Szeged
City
Szeged
Country
Hungary
Facility Name
Mayanei HaYeshua Medical Center
City
Bnei Brak
ZIP/Postal Code
51544
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
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
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