Study With Advanced Vaginal Tactile Imager

Completed

• Conditions: Investigative Techniques

• Registration Number: NCT01848626
• Lead Sponsor: Artann Laboratories

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Imaging performance	3 months

Trial Locations

Locations (1)

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States