Development Study Using Vaginal Tactile Imager

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

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

Key facts

Study ID

NCT01111916

Run by

Artann Laboratories

People needed

31

Starts

2010-03-01

Expected to finish

2010-09-01

Last updated by the study team

2024-01-31

Who can join

Age: 21 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Princeton Urogynecology — Princeton, New Jersey, United States
• Institute for Female Pelvic Medicine and Reconstructuve Surgery — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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