Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix

NCT00955864 | Terminated

• 2 other identifiers: 09018009-CH-0180
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• The uterine cervix is composed of muscle and collagen, which change as women age and under hormonal influences like puberty, pregnancy, and menopause. Yet even though knowledge of structure of the cervix (especially the collagen network) is important to detect problems that may affect pregnancy and other women s health issues, no noninvasive techniques are available to evaluate such changes.
• A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable researchers to better visualize the collagen network in the cervix. Objectives:
• To explore and gain experience with the use of a polarized imaging system to study cervical structure.
• To evaluate the usefulness of a polarized imaging system in studying the cervical structure of healthy nonpregnant women. Eligibility: \- Adult females (at least 18 years of age) who are having regular menstrual cycles and are not on hormonal medications. Design:
• Images will be takes from the cervix in two different phases of menstruation cycle time, one in the follicular phase (before ovulation) and another one in the luteal phase (after ovulation).
• The images of the cervix will be taken with a vaginal speculum in place with the camera attached to a colposcope. The colposcope will illuminate the cervix using polarized light. Three random cervical locations will be photographed

Conditions

Healthy

Keywords

Cervix; Colposcope; Polarized Light; Cervix Structure; Collagen; HV; Healthy Volunteer; Healthy Women

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age female 18 year or greater including IUI patients. Healthy women without significant medical problems who have a uterine cervix.

You may not qualify if:

• Those with symptoms or signs of infection or are currently menstruating.
• Unable or unwilling to give informed consent.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Maul H, Mackay L, Garfield RE. Cervical ripening: biochemical, molecular, and clinical considerations. Clin Obstet Gynecol. 2006 Sep;49(3):551-63. doi: 10.1097/00003081-200609000-00015.

  PMID: 16885662 BACKGROUND

• KRANTZ KE, PHILLIPS WP. Anatomy of the human uterine cervix, gross and microscopic. Ann N Y Acad Sci. 1962 Sep 29;97:551-63. doi: 10.1111/j.1749-6632.1962.tb34666.x. No abstract available.

  PMID: 14035478 BACKGROUND

• Jacques SL, Roman JR, Lee K. Imaging superficial tissues with polarized light. Lasers Surg Med. 2000;26(2):119-29. doi: 10.1002/(sici)1096-9101(2000)26:23.0.co;2-y.

  PMID: 10685085 BACKGROUND

Study Officials

• Amir Gandjbakhche, Ph.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: July 15, 2009
• Study Completion: September 1, 2016
• Last Updated: October 6, 2017

Record last verified: 2016-09-01

Locations

US (1)