Validation of Transvaginal Tactile Imaging

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

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 conditions and characterize the outcome of reconstructive surgery.

Key facts

Study ID

NCT01491334

Run by

Artann Laboratories

People needed

158

Starts

2011-12-01

Expected to finish

2013-11-01

Last updated by the study team

2014-02-25

Who can join

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

You may qualify if…

• 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

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
• Institute of Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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