CClinicalTrials.gg
CompletedNCT01848626Updated Jul 16, 2014

Study With Advanced Vaginal Tactile Imager

An observational study in Investigative Techniques, sponsored by Artann Laboratories. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Artann Laboratories · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
22
Ages
21 Years and older
Sex
Female
01

Study 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.
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Conditions studied

  • Investigative Techniques
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In context

Lead sponsor

Artann Laboratories is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
22 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Imaging performance

    Time frame: 3 months

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Study locations

1 site
  • Princeton Urogynecology
    Princeton, New Jersey 08540, United States
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References and documents

Publications

  • 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. PubMed 25344223 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01848626
Lead sponsor
Artann Laboratories
Responsible party
Sponsor
First posted
May 7, 2013
Start date
Apr 2013
Primary completion
Jan 2014
Completion
Mar 2014
Last update
Jul 16, 2014

Study contacts

Vladimir Egorov, PhD
principal investigator · Artann Laboratories

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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