NCT Number: NCT02209337
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
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
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Notify MeKey information
Age range
18 year–75 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
University of Szeged, Szeged, Hungary
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
No device related serious adverse events
Time frame: up to 12 month
Secondary outcomes
-
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
-
Improvement in POP-Q: points Aa and Ba
Time frame: up to 12 month
-
Improvement in POP-Q point C
Time frame: up to 12 months
-
Achieving normal urinary function
Time frame: up to 12 months
Sponsors and collaborators
Lead sponsor
Lyra Medical Ltd.
Industry
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2018
- First posted
- Aug 5, 2014
- Registry last updated
- Aug 16, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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