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OpenTrials
Completed

NCT Number: NCT01848626

Study With Advanced Vaginal Tactile Imager

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.

Completed

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Imaging performance

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2013
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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