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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01111409
First received: April 26, 2010
Last updated: October 10, 2014
Last verified: December 2011
  Purpose

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).


Condition Intervention
Pelvic Organ Prolapse
Device: VFIX Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VFIX Device: VFIX Device
Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111409

Locations
Australia
QEII Hospital
Brisbane, Australia, QLD 4108
Frances Perry House
Parkville, Australia, VIC 3052
Urogynaecology Unit, Royal Women's Hospital
Parkville, Australia, VIC 3052
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01111409     History of Changes
Other Study ID Numbers: 300-08-013
Study First Received: April 26, 2010
Last Updated: October 10, 2014
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014