Status:
COMPLETED
Study With Advanced Vaginal Tactile Imager
Lead Sponsor:
Artann Laboratories
Conditions:
Investigative Techniques
Eligibility:
FEMALE
21+ years
Brief Summary
The objectives of this study are: 1. To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tol...
Eligibility Criteria
Inclusion
- Adult women (over the age of 21) falling within one of the following groups:
- No evidence of pelvic floor disorder and no prior pelvic surgery;
- Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.
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 :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01848626
Start Date
April 1 2013
End Date
March 1 2014
Last Update
July 16 2014
Active Locations (1)
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1
Princeton Urogynecology
Princeton, New Jersey, United States, 08540