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

NCT03195361 | Completed

• 1 other identifier: CD-14-011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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

Conditions

Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent

Outcome Measures

Primary Outcomes (3)

• Improvement in POP-Q points Aa and Ba

  Points Aa and\\or Ba are less than -1

  36 months

• Improvement in POP-Q point C:

  Point C at -5 or less

  36 months

• No unexpected serious adverse device related events

  36 months

Secondary Outcomes (2)

• Achieving normal urinary function:

  36 Months

• Improvement in Quality Of Life (QoL)

  36 Months

Study Arms (1)

Single-arm

EXPERIMENTAL

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

Device: SRS - Self Retaining Support system

Interventions

SRS - Self Retaining Support system DEVICE

Also known as: transvaginal surgical treatment

Single-arm

Eligibility Criteria

• Age: 50 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 50 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 is suffering from active infection (on antibiotic therapy)
• Patient is planning vaginal delivery
• Patient had previous vaginal mesh surgery
• Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory 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/or polypropylene materials.
• Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
• Diagnosed with mental or emotional disturbance.

Sponsors & Collaborators

• Lyra Medical Ltd.: lead

Study Sites (3)

Mayanei HaYeshua Medical Center

Bnei Brak, 51544, Israel

Location

Ziv Medical center

Safed, Israel

Location

Asaf HaRofeh Medical Center

Zrifin, 70300, Israel

Location

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: May 1, 2016
• First Posted: June 22, 2017
• Study Start: March 1, 2016
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

IL (3)