Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04107181
Other study ID # Pro00008173_1
Secondary ID R01CA239268-04
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2016
Est. completion date February 1, 2025

Study information

Verified date January 2024
Source Duke University
Contact Nimmi Ramanujam, PhD
Phone 9196605307
Email nimmi@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 305
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: Healthy female - Aged 21-65 years - Have had a pelvic exam - Have conversational proficiency in English - Highest level of education attained Exclusion Criteria: - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
Behavioral:
Interviews only
Healthy volunteer interviews

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Duke University Korle-Bu Teaching Hospital, Accra, Ghana, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A