Study With Advanced Vaginal Tactile Imager

Artann Laboratories

Status: Completed

Conditions: Investigative Techniques

Study type: Observational

Funder types: Industry

Identifiers

NCT01848626

VTI 04

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Adult women (over the age of 21) falling within one of the following groups:

1. No evidence of pelvic floor disorder and no prior pelvic surgery;
2. Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.

Exclusion criteria

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Recent (less than three months) pelvic surgery;
7. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
8. Severe hemorrhoids;
9. Surgically absent rectum or bladder;
10. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician.