Study With Advanced Vaginal Tactile Imager

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01848626

Enrollment

Registered

2013-05-07

Start date

2013-04-30

Completion date

2014-03-31

Last updated

2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigative Techniques

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Imaging performance	3 months

Countries

United States

Outcome results