Cervical CancerNCT02272075
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
A study testing Mobile OCT M3 scope in people with Cervical Cancer, run by Scripps Health at 1 site in United States.
Trial summary
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Mobile OCT M3 scope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.
Read the detailed description
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared
- Conditions
- Cervical Cancer
- Being tested
- Mobile OCT M3 scope
- Keywords
- screeening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile OCT M3 scopeDevice
| Study group | Role | What they receive |
|---|---|---|
| active colposcope | Active comparator | Mobile OCT M3 scope Receives: Device: Mobile OCT M3 scope |
| Standard of Care | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
image non-inferiority
imafge non-inferiority
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Kahn, Scripps Health
- Investigators
- Bruce Kahn, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272075
- Sponsor's protocol ID
- Scripps-Mobile OCT 1
- Status last verified
- May 2022
- First submitted
- 20 Oct 2014
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT02272075
- Acronym / sponsor ID
- Scripps-Mobile OCT 1
- Conditions
- Cervical Cancer
- Keywords
- screeening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.
Detailed description
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active colposcope | Active comparator | Device: Mobile OCT M3 scopeMobile OCT M3 scope |
| Standard of Care | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile OCT M3 scope | Device | active colposcope |
Primary outcome
image non-inferiority
Time frame: 6 months
imafge non-inferiority
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Kahn, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile OCT M3 scope in people with Cervical Cancer, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
image non-inferiority (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.