Study With Advanced Vaginal Tactile Imager

NCT01848626 | Completed

• 1 other identifier: VTI 04
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 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. 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. 3.To test the data collection technique and establish a reliable examination procedure.

Conditions

Investigative Techniques

Outcome Measures

Primary Outcomes (1)

• Imaging performance

  3 months

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females, presenting to the urogynecological office for a vaginal examination with normal pelvic floor organs, referred to gynecologic examination due to pelvic organ prolapse concern or earlier diagnosed with pelvic organ prolapse, will be considered eligible as volunteers to be enrolled in the clinical studies.

You may qualify if:

• Adult women (over the age of 21) falling within one of the following groups:
• No evidence of pelvic floor disorder and no prior pelvic surgery;
• Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.

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.

Sponsors & Collaborators

• Artann Laboratories: lead

Study Sites (1)

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

• van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.

  PMID: 25344223 DERIVED

Study Officials

• Vladimir Egorov, PhD

  Artann Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (1)