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OpenTrials
Completed

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged, Szeged, Hungary

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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

SRS

Device

Primary outcomes

  1. No device related serious adverse events

    Time frame: up to 12 month

Secondary outcomes

  1. 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

  2. Improvement in POP-Q: points Aa and Ba

    Time frame: up to 12 month

  3. Improvement in POP-Q point C

    Time frame: up to 12 months

  4. 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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