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Validation of Transvaginal Tactile Imaging (VTI-03)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01491334
First received: December 12, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Validation Study With Transvaginal Tactile Imaging

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • Effectiveness in assessment of the pelvic floor tissue conditions. [ Time Frame: Two years. ] [ Designated as safety issue: Yes ]
  • Ability in early detection of prolapse conditions. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Ability in characterization of the outcome of pelvic floor reconstructive surgery. [ Time Frame: Two years. ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
  1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
  2. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
  3. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
  4. 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).
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The patient pool will comprise of 200 female patients.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491334

Locations
United States, New Jersey
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
United States, Pennsylvania
Institute of Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Artann Laboratories
Investigators
Principal Investigator: Vladimir Egorov, Ph.D. Artann Laboratories, Inc.
  More Information

Publications:
Egorov V, van Raalte H, Lucente V. Tactile imaging and tissue elasticity as a marker of pelvic floor conditions. International Urogynecological Association: 38th Annual Meeting, Dublin, Ireland, May 28-June 1, 2013.
van Raalte H, Lucente V, Egorov V. Measuring outcome in urogynecological surgery by 3-D tactile imaging: First clinical experience. International Urogynecological Association: 38th Annual Meeting, Dublin, Ireland, May 28-June 1, 2013.
van Raalte H, Egorov V, Lucente V. Tissue elasticity as a marker of pelvic floor conditions: Clinical results. Proceedings of the 11th International Tissue Elasticity Conference, Deauville, France, October 2-5, 2012: 46.

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01491334     History of Changes
Other Study ID Numbers: VTI-03, 1R43AG034714
Study First Received: December 12, 2011
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Artann Laboratories:
POP
Pelvic Floor
Pelvic Organ Prolapse

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014