Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to clinically assess the safety and performance of the EndoFast
      Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.
    

Detailed description: 
      Background:

      Pelvic Organ Prolapse represents a significant problem worldwide and may have a significant
      negative impact on a woman's quality of life. The uterus, rectum and the bladder are held in
      their normal positions just above the inner end of the vagina by a "hammock" made up of
      supportive muscles and ligaments. Wear and tear on these supportive structures in the pelvis
      can allow the uterus, the bladder, the bowels, the vaginal vault or the rectum to sag through
      the muscle and ligament layers. When this occurs, the rectum, uterus, bowels or bladder can
      create a bulge into the vagina. In severe cases, it is possible for the sagging rectum,
      uterus, bowels or bladder to work its way down far enough that the bulge can appear at the
      vagina's opening or even protrude from the opening. Pelvic Organ Prolapse causes significant
      discomfort to the patients being associated with urinary incontinence, voiding difficulty
      culminating with urinary retention, constipation, pain during sexual intercourse, local
      discomfort, etc.

      Treatment Options When symptoms occur, many patients initially opt for conservative
      treatment. Pelvic exercises and vaginal support are the current mainstays of non surgical
      management. In addition, patients who are poor surgical candidates or are strongly
      disinclined to surgery can be offered vaginal support (pessaries) for symptom relief. Topical
      estrogen is an important adjunct in the conservative management of patients with Pelvic Organ
      Prolapse. However, the primary management strategy for severe Pelvic Organ Prolapse is
      surgical. The exact treatment choice will depend on the severity of the prolapse and whether
      there are any related pelvic floor defects.

      Endogun Medical Systems Ltd. has developed an innovative, minimally-invasive system for
      repair of Pelvic Floor Prolapse. The EndoFast Reliant™ system is a new concept of reinforcing
      the vaginal wall with a proprietary system comprised of a mesh and soft tissue fasteners in a
      minimally-invasive way. The fasteners can be deployed easily and swiftly in narrow spaces
      into soft tissue and can support substantially more weight than needed for Pelvic Organ
      Prolapse repair. Following many pre-clinical tests, the EndoFast Reliant™ system is now
      available for clinical evaluation.

      The objective of this study is to evaluate the safety and performance of the EndoFast
      Reliant™ system for treatment of Pelvic Organ Prolapse.

      In particular:

        -  The study's primary goal is to clinically assess the safety of the EndoFast Reliant™ as
           a minimally-invasive procedure for vaginal wall reinforcement.

        -  The study's secondary goal is to clinically evaluate the performance of the EndoFast
           Reliant™ system as a minimally-invasive procedure for vaginal wall reinforcement by
           evaluating the improvement in Pelvic Organ Prolapse using the POPQ grading system.

      Study Procedures and Follow up:

      Pre-treatment tests and inspection will be performed within 4 months prior to surgery.

      Approximately two weeks, three months and six months after the surgery the patient will be
      invited for physician examination and laboratory tests.

      Additional Study Measures:

      In addition to the endpoint parameters, the following study measures will be collected:

        -  Symptoms relief and Quality of Life (QOL) considerations.

        -  Sexual Function considerations, as documented using the Female Sexual Function (FSFI)
           questionnaire;

        -  Assessment of the physician's satisfaction.
    

Intervention name(s): EndoFast Reliant™ system for Pelvic Organ Prolapse repair
Intervention type(s): Device
Intervention description(s): The EndoFast Reliant™ system is a new concept of reinforcing the vaginal wall with proprietary mesh and soft-tissue Fasteners in a minimally-invasive procedure.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment