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

NCT01111409 | Completed

• 1 other identifier: 300-08-013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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).

Conditions

Pelvic Organ Prolapse

Study Arms (1)

VFIX

EXPERIMENTAL

Device: VFIX Device

Interventions

VFIX Device DEVICE

Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor

VFIX

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (3)

QEII Hospital

Brisbane, QLD 4108, Australia

Location

Frances Perry House

Parkville, VIC 3052, Australia

Location

Urogynaecology Unit, Royal Women's Hospital

Parkville, VIC 3052, Australia

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David Robinson, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2011
• Last Updated: October 13, 2014

Record last verified: 2011-12

Locations

AU (3)