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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195361
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Lyra Medical Ltd.

Tracking Information
First Submitted Date  ICMJE May 1, 2016
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • Improvement in POP-Q points Aa and Ba [ Time Frame: 36 months ]
    Points Aa and\or Ba are less than -1
  • Improvement in POP-Q point C: [ Time Frame: 36 months ]
    Point C at -5 or less
  • No unexpected serious adverse device related events [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03195361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • Achieving normal urinary function: [ Time Frame: 36 Months ]
    Patient does not experience voiding dysfunction and have negative Urinary Cough Test.
  • Improvement in Quality Of Life (QoL) [ Time Frame: 36 Months ]
    Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Intervention  ICMJE Device: SRS - Self Retaining Support system
Other Name: transvaginal surgical treatment
Study Arms  ICMJE 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
Intervention: Device: SRS - Self Retaining Support system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195361
Other Study ID Numbers  ICMJE CD-14-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lyra Medical Ltd.
Study Sponsor  ICMJE Lyra Medical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lyra Medical Ltd.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP