VTI-03: Validation of Transvaginal Tactile Imaging

Sponsor

Artann Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT01491334

Collaborator

National Institute on Aging (NIA) (NIH)

158

Enrollment

Locations

Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse

Detailed Description

The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women).

Study Design

Study Type:

Observational

Actual Enrollment :

158 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Clinical Validation Study With Transvaginal Tactile Imaging

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Asymptomatic Asymptomatic women presenting at various ages without prolapse condition.
Symptomatic Symptomatic women presenting with prolapse conditions with no prior surgeries and women presenting with surgery scheduled with or without prior surgery.

Outcome Measures

Primary Outcome Measures

Effectiveness in assessment of the pelvic floor tissue conditions. [Two years.]
Ability in early detection of prolapse conditions. [One Year]
Ability in characterization of the outcome of pelvic floor reconstructive surgery. [Two years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
No evidence of pelvic organ prolapse and no prior pelvic surgery
Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princeton Urogynecology	Princeton	New Jersey	United States	08540
2	Institute of Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania	United States	18103