NCT02272075

Brief Summary

This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

October 20, 2014

Last Update Submit

May 10, 2022

Conditions

Cervical Cancer

Keywords

screeening

Outcome Measures

Primary Outcomes (1)

  • image non-inferiority

    imafge non-inferiority

    6 months

Study Arms (2)

active colposcope

ACTIVE COMPARATOR

Mobile OCT M3 scope

Device: Mobile OCT M3 scope

Standard of Care

NO INTERVENTION

Standard of Care

Interventions

Mobile OCT M3 scopeDEVICE
active colposcope

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bruce Kahn, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

US(1)