HealthyNCT00955864
Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix
An observational study of Healthy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2009to 1 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age female 18 year or greater including IUI patients. Healthy women without significant medical problems who have a uterine cervix.
Who cannot join
- Those with symptoms or signs of infection or are currently menstruating.
- Any medical condition that, in the opinion of Principal Investigator, would preclude the inclusion of a patient onto this research study.
- Unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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
Read the detailed description
The uterine cervix is composed of muscle and collagen which changes as women age and under hormonal influences like after puberty, during pregnancy, and with menopause. It has been determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the cervix ripens in preparation for labor, cervical collagen concentration is decreases and solubility increases. However, there are no noninvasive techniques available to evaluate such structural changes especially of the collagen of cervix. Developing a non-invasive way to evaluate the characteristics of cervical structure and collagen may aid in identifying women who are at risk of early cervical dilation. A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable us to visualize the collagen network in cervix. The purpose of this study is to explore the usefulness of polarized camera images in evaluating the cervical structure of healthy women at different ages. After evaluating and validating this approach in healthy, nonpregnant women, we plan to assess the cervical structure of pregnant women, some of whom may be at risk of early cervical dilation.
- Conditions
- Healthy
- Keywords
- Cervix, Colposcope, Polarized Light, Cervix Structure, Collagen, HV, Healthy Volunteer, Healthy Women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study start15 Jul 2009
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amir Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955864
- Sponsor's protocol ID
- 090180
- Other IDs
- 09-CH-0180
- Status last verified
- 1 Sep 2016
- First submitted
- 7 Aug 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
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.
PubMed 16885662KRANTZ 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.
PubMed 14035478Jacques 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.
PubMed 10685085
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Non-Ionizing Polarized Imaging System to Assess Structure of Cervix
- ClinicalTrials.gov ID
- NCT00955864
- Acronym / sponsor ID
- 090180
- Conditions
- Healthy
- Keywords
- Cervix, Colposcope, Polarized Light, Cervix Structure, Collagen, HV, Healthy Volunteer, Healthy Women
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 15 Jul 2009
- Study completion
- 1 Sep 2016
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The uterine cervix is composed of muscle and collagen which changes as women age and under hormonal influences like after puberty, during pregnancy, and with menopause. It has been determined that during pregnancy, prior to cervical ripening, cross linked collagen fibrils are organized in tight bundles which provide tensile strength, rigidity and stiffness. As the cervix ripens in preparation for labor, cervical collagen concentration is decreases and solubility increases. However, there are no noninvasive techniques available to evaluate such structural changes especially of the collagen of cervix. Developing a non-invasive way to evaluate the characteristics of cervical structure and collagen may aid in identifying women who are at risk of early cervical dilation. A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable us to visualize the collagen network in cervix. The purpose of this study is to explore the usefulness of polarized camera images in evaluating the cervical structure of healthy women at different ages. After evaluating and validating this approach in healthy, nonpregnant women, we plan to assess the cervical structure of pregnant women, some of whom may be at risk of early cervical dilation.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age female 18 year or greater including IUI patients. Healthy women without significant medical problems who have a uterine cervix.
Key exclusion criteria (3 listed)
- Those with symptoms or signs of infection or are currently menstruating.
- Any medical condition that, in the opinion of Principal Investigator, would preclude the inclusion of a patient onto this research study.
- Unable or unwilling to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 16885662Maul 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.
- Background: PubMed 14035478KRANTZ 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.
- Background: PubMed 10685085Jacques 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955864, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.