Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2006-05-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Colposcope
Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
Optical Spectroscopy Bench-Top System
This device is a bench-top optical spectrometer
Portable Optical Spectrometer
This device is a portable optical spectrometer
Transvaginal colposcope
Interventions
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Optical Spectroscopy Bench-Top System
This device is a bench-top optical spectrometer
Portable Optical Spectrometer
This device is a portable optical spectrometer
Transvaginal colposcope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* LEEP for the treatment of cervical cancer in early stages.
* Follow-up Pap smear in surveillance
Exclusion Criteria
* patients will be excluded if she has had a recent episode of bleeding or preterm labor.
* Subjects who are not competent to give consent will excluded
18 Years
FEMALE
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Nimmi Ramanujam, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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References
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Chang VT, Cartwright PS, Bean SM, Palmer GM, Bentley RC, Ramanujam N. Quantitative physiology of the precancerous cervix in vivo through optical spectroscopy. Neoplasia. 2009 Apr;11(4):325-32. doi: 10.1593/neo.81386.
Asiedu MN, Agudogo JS, Dotson ME, Skerrett E, Krieger MS, Lam CT, Agyei D, Amewu J, Asah-Opoku K, Huchko M, Schmitt JW, Samba A, Srofenyoh E, Ramanujam N. A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. Sci Rep. 2020 Oct 6;10(1):16570. doi: 10.1038/s41598-020-72219-9.
Related Links
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PI website to see ongoing research
Other Identifiers
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Pro00008173
Identifier Type: -
Identifier Source: org_study_id
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