Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

NCT02209337 | Completed

• 1 other identifier: CD-14-005
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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

Conditions

Anterior Vaginal Wall Prolapse; Vaginal Apex/Uterine Prolapse

Outcome Measures

Primary Outcomes (1)

• No device related serious adverse events

  up to 12 month

Secondary Outcomes (4)

• 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)

  up to 12 months

• Improvement in POP-Q: points Aa and Ba

  up to 12 month

• Improvement in POP-Q point C

  up to 12 months

• Achieving normal urinary function

  up to 12 months

Study Arms (1)

SRS-I

EXPERIMENTAL

Implantation of SRS-I

Device: SRS

Interventions

SRS DEVICE

SRS-I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyra Medical Ltd.: lead

Study Sites (3)

University of Szeged

Szeged, Hungary

Location

Mayanei HaYeshua Medical Center

Bnei Brak, 51544, Israel

Location

Asaf HaRofeh Medical Center

Zrifin, 70300, Israel

Location

Study Officials

• Gil Levi, Dr.

  Mayanei HaYeshua Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2018
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

HU (1); IL (2)