DysplasiaPhase 4NCT00358111
Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
A Phase 4 study testing Luma Cervical Imaging System in people with Dysplasia and Cancer, run by SpectraScience at 2 sites in United States.
Trial summary
This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Luma Cervical Imaging System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Nov 2010
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented abnormal pap test
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Women's Interventional Health
Encinitas, California, 92024
U of Iowa Health Center
Iowa City, Iowa, 52242
About this study
Official title: A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.
- Being tested
- Luma Cervical Imaging System
- Keywords
- high-grade disease, Cervical examination, targeting biopsies, dysplasia, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luma Cervical Imaging SystemDevice
Colposcopy using LUMA Cervical Imaging System
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.
Measured: ongoing - estimated at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: PMA withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysplasiaStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectraScience
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor
- Investigators
- Jim Hitchin, Study chair, SpectraScience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358111
- Sponsor's protocol ID
- 302925
- Status last verified
- May 2014
- First submitted
- 27 Jul 2006
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
- ClinicalTrials.gov ID
- NCT00358111
- Acronym / sponsor ID
- 302925
- Keywords
- high-grade disease, Cervical examination, targeting biopsies, dysplasia, cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PMA withdrawn
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SpectraScienceUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- Jul 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Jul 2006 (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 is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented abnormal pap test
Key exclusion criteria (0 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 |
|---|---|---|
| Luma Cervical Imaging SystemColposcopy using LUMA Cervical Imaging System | Device | – |
Primary outcome
Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.
Time frame: ongoing - estimated at 3 years
Results and safety
The study was stopped early (reason given: PMA withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Jim Hitchin study chair
SpectraScience
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Luma Cervical Imaging System in people with Dysplasia and Cancer, run by SpectraScience at 2 sites 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PMA withdrawn). Results are not available in the source record.
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?
Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed. (time frame: ongoing - estimated at 3 years). 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 13 May 2014.