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).

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: VFIX Device

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia, QLD 4108
    • QEII Hospital
  • Parkville, Australia, VIC 3052
    • Frances Perry House
  • Parkville, Australia, VIC 3052
    • Urogynaecology Unit, Royal Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VFIX	Device: VFIX Device; Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 10, 2014
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 300-08-013