Status:
COMPLETED
Validation of Transvaginal Tactile Imaging
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Brief Summary
The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse cond...
Detailed Description
1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1. 2. The device will detect significant differen...
Eligibility Criteria
Inclusion
- Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
- No evidence of pelvic organ prolapse and no prior pelvic surgery
- Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
- Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled
Exclusion
- Active skin infection or ulceration within the vagina
- Presence of a vaginal septum;
- Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
- Ongoing radiation therapy for pelvic cancer;
- Impacted stool
- Recent (less than three months) pelvic surgery;
- Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
- Severe hemorrhoids
- Surgically absent rectum or bladder
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01491334
Start Date
December 1 2011
End Date
November 1 2013
Last Update
February 25 2014
Active Locations (2)
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1
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
2
Institute of Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103