Development Study Using Vaginal Tactile Imager

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

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Detailed Description

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Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. no evidence of pelvic organ prolapse and no prior pelvic surgery
2. stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
3. no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)

Exclusion Criteria

1. patients with active skin infection, tissue breakdown or ulceration
2. patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
3. recent pelvic surgery with less than 3-month interval from surgery

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes