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

Ethicon

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: VFIX Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01111409

300-08-013

Details and patient eligibility

About

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).

Full description

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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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