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

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

VFIX Device

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

QEII Hospital
Frances Perry House
Urogynaecology Unit, Royal Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VFIX

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01111409

First Posted

April 26, 2010

Last Updated

October 10, 2014

Sponsor

Ethicon, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01111409

Brief Title

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

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ethicon, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VFIX

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

VFIX Device

Intervention Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Robinson, MD

Organizational Affiliation

Ethicon, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

QEII Hospital

City

Brisbane

ZIP/Postal Code

QLD 4108

Country

Australia

Facility Name

Frances Perry House

City

Parkville

ZIP/Postal Code

VIC 3052

Country

Australia

Facility Name

Urogynaecology Unit, Royal Women's Hospital

City

Parkville

ZIP/Postal Code

VIC 3052

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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