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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA239268-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Korle-Bu Teaching Hospital, Accra, Ghana | OTHER |
| National Cancer Institute (NCI) | NIH |
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The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient surveillance | Experimental | The introducer will be used during annual Pap smears for cervical cancer screening. |
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| Healthy Volunteers | Experimental | There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Introducer "calla" device | Device | The research introducer will be used after the patient consents prior to the annual pap smear. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of introducer | We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum | Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) |
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Inclusion Criteria:
Healthy female
Exclusion Criteria:
- Pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nimmi Ramanujam, PhD | Contact | 9196605307 | nimmi@duke.edu | |
| Jennifer Gallagher, BA | Contact | 9199701551 | jennifer.gallagher@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nimmi Ramanujam, PhD | Duke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Interviews only | Behavioral | Healthy volunteer interviews |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |