Study With Advanced Vaginal Tactile Imager

Completed

Conditions studied: Investigative Techniques

In brief

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 tolerance; 2. 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; 3. To test the data collection technique and establish a reliable examination procedure.

Key facts

Study ID

NCT01848626

Run by

Artann Laboratories

People needed

22

Starts

2013-04-01

Expected to finish

2014-03-01

Last updated by the study team

2014-07-16

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Princeton Urogynecology — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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