Clinical trial NCT01111409: A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
Official title: A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: QEII Hospital
city: Parkville
country: Australia
facility: Frances Perry House
city: Parkville
country: Australia
facility: Urogynaecology Unit, Royal Women's Hospital
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References: