Trials / Completed
CompletedNCT01111409
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VFIX Device | Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2010-11-01
- Completion
- 2011-06-01
- First posted
- 2010-04-27
- Last updated
- 2014-10-13
Locations
3 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT01111409. Inclusion in this directory is not an endorsement.