A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.

Inclusion Criteria:

• Age greater than or equal to 18 years
• Subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing
• Subject with apical prolapse at stage II or more and requiring treatment (C should be at least -1 cm)
• On reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen
• If applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment
• The vaginal apex can reach the Sacrospinous Ligament (SSL) on exam
• Subjects are allowed concurrent incontinence procedure as required
• Concurrent perineal repairs and excision of excess vaginal tissue repairs as required
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent

Exclusion Criteria:

• Additional surgical intervention for POP repairs concurrent to the VFIX procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc)
• Experimental drug or experimental medical device within 3 months prior to the planned procedure
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Previous hysterectomy within 6 months of scheduled surgery.
• Coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery
• Nursing or pregnant
• Presence of cancers of the vagina, cervix, or uterus
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol