Clinical Trials Logo
  1. Home
  2. Cervical Cancer
  3. NCT05388162
  4. Details
NCT05388162 Clinical Trial

A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.

Cervical Cancer Clinical Trial

Official title:
Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05388162
Other study ID # Smart-phone based culposcope
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date March 2016

Study information
Verified date November 2022
Source Scripps Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

When a woman has an abnormal pap smear or tests positive for a high risk strain of the HPV virus, the current standard of care includes culposcopic examination of the cervix with biopsy. A culposcope is essentially a microscope for examining the cervix. Culposcopes cost $5-10,000 each. The device being tested in this trial is an adaptor for a smart phone that will cost ~ $125. The larger goal of this line of studies see if the images obtained using the smart phone adaptor are non-inferior to those obtained with standard culposcopes. If the device is found to provide images equal to those of standard culposscopes, it could save thousands of dollars in healthcare expenditure currently that go to the purchase and maintenance of culposcopes. This has potential world-wide applications, especially for resource poor countries. This initial trial is a non-inferiority trial to compare the images obtained with the smart phone based device of those obtained by a standard culposcope

Description:

See above.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy - Exclusion Criteria: none -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mobile colposcope
It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.

Locations
Country Name City State
United States Scripps Clinic San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine of the smart-phone based cervical imaging device provides non-inferior image to that obtained using a standard culposcope for the detecton of cervical dysplasia See above. 1 day
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