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Study With Advanced Vaginal Tactile Imager

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ClinicalTrials.gov Identifier: NCT01848626
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Artann Laboratories

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.

Condition or disease
Investigative Techniques

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study With Advanced Vaginal Tactile Imager
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014



Primary Outcome Measures :
  1. Imaging performance [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848626


Locations
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United States, New Jersey
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Artann Laboratories
Investigators
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Principal Investigator: Vladimir Egorov, PhD Artann Laboratories

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01848626     History of Changes
Other Study ID Numbers: VTI 04
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014