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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: VFIX Device

• Registration Number: NCT01111409
• Lead Sponsor: Ethicon, Inc.

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2010-11
• Study Completion: 2011-06
• Status Verified: 2011-12
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VFIX	VFIX Device	-

Trial Locations

Locations (3)

QEII Hospital; 🇦🇺 Brisbane, Australia

Frances Perry House; 🇦🇺 Parkville, Australia

Urogynaecology Unit, Royal Women's Hospital; 🇦🇺 Parkville, Australia