Study With Advanced Vaginal Tactile Imager

Artann Laboratories1 site in 1 country22 target enrollmentApril 2013

Overview

The objectives of this study are:

To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
To test the data collection technique and establish a reliable examination procedure.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

March 2014

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Sponsor

Artann Laboratories

Responsible Party

Sponsor

•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.