Study With Advanced Vaginal Tactile Imager

Investigative Techniques Clinical Trial

Official title:

Study With Advanced Vaginal Tactile Imager

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848626
• Other study ID #: VTI 04
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: July 14, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Investigative Techniques

Locations

Country	Name	City	State
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Artann Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging performance		3 months	Yes