Cervical DysplasiaNCT04915495
The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
A study testing LuViva Advanced Cervical Scan in people with Cervical Dysplasia, run by Guided Therapeutics at 4 sites in United States.
Trial summary
This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- LuViva Advanced Cervical Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 May 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Able to read or understand and give informed consent
- Referral Pap test within 120 days
- Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.*
- Notes: The rationale for defining the referral inclusion criteria as women scheduled for colposcopy is that this group has been identified with having a significant likelihood of being diagnosed with CIN2+ over the two year period after being referred to colposcopy because of an abnormal screening test or tests. For example, the ALTS results showed that women with ASC-US plus high-risk HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10% to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been shown that this threshold also carries with it a 4% or greater likelihood of immediate CIN3+ (12).
Who cannot join
- Pregnancy
- Menstruating on the day of colposcopy and LuViva test
- Radiation therapy to her genitourinary system within 1 year
- Prior hysterectomy in which cervix was removed
- Congenital anatomical cervical variant (e.g., double cervix)
- Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
Show all 12Show fewer
- Post-coital or other significant bleeding at the time of the exam
- Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the Investigator, to interfere with a Pap test or colposcopy, resulting from inflammation, bacterial infection or other sources
- History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
- Undergoing phototherapy
- Recent use of photosensitizing agents, such as fluoroquinolones or retinoids
- Under-screened populations - defined as those women who have not been screened within the past 5 years who also screen positive for any HPV genotype
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Emory University- Winship Cancer Institute
Atlanta, Georgia, 30322
Great Lakes Bay Health Centers
Bay City, Michigan, 48706
University of Alabama Birmingham- Heersink School of Medicine
Birmingham, Alabama, 35233
Tidewater Clinical Research
Norfolk, Virginia, 23502
About this study
This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.
Read the detailed description
This study is a matched pair design, single-arm study with the following two treatments: current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test, all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the colposcopist noting on the case report form (CRF), locations of lesions with colposcopy impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that include the use on Lugol's solution and green/blue filters. The colposcopist will note on the CRF any additional lesions that became evident as a result of these enhanced measures, regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies identified using SOC practices will be placed in vials labeled "SOC Samples". Biopsies identified using enhanced practices will be placed in vials labeled "Additional Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ) in which a lesion was not observed. These biopsies will be placed in the vial labeled "Additional Samples". Once all colposcopy procedures are completed, biopsies of lesions collected, and biopsies of any non-lesion identified quadrants collected, an ECC, if indicated, will be collected. If an ECC would have been taken per SOC practices, it will be placed in a vial labeled "SOC ECC". ECCs collected per enhanced procedures will be placed in a vial labeled "Additional ECC". The study is a matched pair design because all subjects are tested with the LuViva device, and all will undergo both the nominal (minimal) colposcopy and biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be determined 1) Whether enhanced procedures can be justified when the LuViva test indicates High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk, that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for increased detection of CIN2+. Subjects will be enrolled during their normally scheduled colposcopy visit and will be recruited from the pool of patients that are referred to colposcopy based on the ASCCP Guidelines published in April 2020. The total number of enrolled female subjects pooled across all clinical sites combined will not exceed 500 in order to target an evaluable cohort of approximately 400 women.
- Conditions
- Cervical Dysplasia
- Being tested
- LuViva Advanced Cervical Scan
- Keywords
- Cervical cancer, dysplasia, detection
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuViva Advanced Cervical ScanDiagnostic test
Multimodal hyperspectral device
| Study group | Role | What they receive |
|---|---|---|
| Singe-arm Study | Experimental | Experimental device being evaluated for sensitivity and specificity. Receives: Diagnostic Test: LuViva Advanced Cervical Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Diagnostic Device
LuViva's ability to correctly identify diseased tissue. LuViva result indicated High-risk and the pathology results indicate the presence of disease cervical tissue.
Measured: up to 60 days after completion of enrollment
Secondary outcomes (1)
Specificity of Diagnostic Device
LuViva's ability to correctly identify non diseased tissue. LuViva result indicated Low-risk and the pathology results did not indicate the presence of disease cervical tissue.
Measured: up to 60 days after completion of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start5 May 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cervical 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guided Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915495
- Sponsor's protocol ID
- CC-03-01-2020
- Status last verified
- Mar 2025
- First submitted
- 28 May 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Sherman ME, Schiffman M, Cox JT; Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study Group. Effects of age and human papilloma viral load on colposcopy triage: data from the randomized Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS). J Natl Cancer Inst. 2002 Jan 16;94(2):102-7. doi: 10.1093/jnci/94.2.102.
PubMed 11792748Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ; ASCCP-Sponsored Consensus Conference. 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA. 2002 Apr 24;287(16):2120-9. doi: 10.1001/jama.287.16.2120.
PubMed 11966387ASCUS-LSIL Traige Study (ALTS) Group. Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance. Am J Obstet Gynecol. 2003 Jun;188(6):1383-92. doi: 10.1067/mob.2003.457.
PubMed 12824967Massad LS, Collins YC. Strength of correlations between colposcopic impression and biopsy histology. Gynecol Oncol. 2003 Jun;89(3):424-8. doi: 10.1016/s0090-8258(03)00082-9.
PubMed 12798706Mitchell MF, Schottenfeld D, Tortolero-Luna G, Cantor SB, Richards-Kortum R. Colposcopy for the diagnosis of squamous intraepithelial lesions: a meta-analysis. Obstet Gynecol. 1998 Apr;91(4):626-31. doi: 10.1016/s0029-7844(98)00006-4.
PubMed 9540955Wentzensen N, Massad LS, Mayeaux EJ Jr, Khan MJ, Waxman AG, Einstein MH, Conageski C, Schiffman MH, Gold MA, Apgar BS, Chelmow D, Choma KK, Darragh TM, Gage JC, Garcia FAR, Guido RS, Jeronimo JA, Liu A, Mathews CA, Mitchell MM, Moscicki AB, Novetsky AP, Papasozomenos T, Perkins RB, Silver MI, Smith KM, Stier EA, Tedeschi CA, Werner CL, Huh WK. Evidence-Based Consensus Recommendations for Colposcopy Practice for Cervical Cancer Prevention in the United States. J Low Genit Tract Dis. 2017 Oct;21(4):216-222. doi: 10.1097/LGT.0000000000000322.
PubMed 28953109Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.
PubMed 23591399Huh WK, Papagiannakis E, Gold MA. Observed Colposcopy Practice in US Community-Based Clinics: The Retrospective Control Arm of the IMPROVE-COLPO Study. J Low Genit Tract Dis. 2019 Apr;23(2):110-115. doi: 10.1097/LGT.0000000000000454.
PubMed 30694884Perkins RB, Guido RS, Castle PE, Chelmow D, Einstein MH, Garcia F, Huh WK, Kim JJ, Moscicki AB, Nayar R, Saraiya M, Sawaya GF, Wentzensen N, Schiffman M; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020 Apr;24(2):102-131. doi: 10.1097/LGT.0000000000000525. No abstract available.
PubMed 32243307Cheung LC, Egemen D, Chen X, Katki HA, Demarco M, Wiser AL, Perkins RB, Guido RS, Wentzensen N, Schiffman M. 2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation. J Low Genit Tract Dis. 2020 Apr;24(2):90-101. doi: 10.1097/LGT.0000000000000528.
PubMed 32243306Waxman AG, Conageski C, Silver MI, Tedeschi C, Stier EA, Apgar B, Huh WK, Wentzensen N, Massad LS, Khan MJ, Mayeaux EJ Jr, Einstein MH, Schiffman MH, Guido RS. ASCCP Colposcopy Standards: How Do We Perform Colposcopy? Implications for Establishing Standards. J Low Genit Tract Dis. 2017 Oct;21(4):235-241. doi: 10.1097/LGT.0000000000000336.
PubMed 28953112Jeronimo J, Schiffman M. Colposcopy at a crossroads. Am J Obstet Gynecol. 2006 Aug;195(2):349-53. doi: 10.1016/j.ajog.2006.01.091. Epub 2006 May 3.
PubMed 16677597Gage JC, Hanson VW, Abbey K, Dippery S, Gardner S, Kubota J, Schiffman M, Solomon D, Jeronimo J; ASCUS LSIL Triage Study (ALTS) Group. Number of cervical biopsies and sensitivity of colposcopy. Obstet Gynecol. 2006 Aug;108(2):264-72. doi: 10.1097/01.AOG.0000220505.18525.85.
PubMed 16880294Nam K, Chung S, Kwak J, Cha S, Kim J, Jeon S, Bae D. Random biopsy after colposcopy-directed biopsy improves the diagnosis of cervical intraepithelial neoplasia grade 2 or worse. J Low Genit Tract Dis. 2010 Oct;14(4):346-51. doi: 10.1097/LGT.0b013e3181e9635b.
PubMed 20885163
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT04915495
- Acronym / sponsor ID
- CC-03-01-2020
- Conditions
- Cervical Dysplasia
- Keywords
- Cervical cancer, dysplasia, detection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guided TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Jun 2021 (actual)
- 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 study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.
Detailed description
This study is a matched pair design, single-arm study with the following two treatments: current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test, all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the colposcopist noting on the case report form (CRF), locations of lesions with colposcopy impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that include the use on Lugol's solution and green/blue filters. The colposcopist will note on the CRF any additional lesions that became evident as a result of these enhanced measures, regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies identified using SOC practices will be placed in vials labeled "SOC Samples". Biopsies identified using enhanced practices will be placed in vials labeled "Additional Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ) in which a lesion was not observed. These biopsies will be placed in the vial labeled "Additional Samples". Once all colposcopy procedures are completed, biopsies of lesions collected, and biopsies of any non-lesion identified quadrants collected, an ECC, if indicated, will be collected. If an ECC would have been taken per SOC practices, it will be placed in a vial labeled "SOC ECC". ECCs collected per enhanced procedures will be placed in a vial labeled "Additional ECC". The study is a matched pair design because all subjects are tested with the LuViva device, and all will undergo both the nominal (minimal) colposcopy and biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be determined 1) Whether enhanced procedures can be justified when the LuViva test indicates High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk, that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for increased detection of CIN2+. Subjects will be enrolled during their normally scheduled colposcopy visit and will be recruited from the pool of patients that are referred to colposcopy based on the ASCCP Guidelines published in April 2020. The total number of enrolled female subjects pooled across all clinical sites combined will not exceed 500 in order to target an evaluable cohort of approximately 400 women.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singe-arm Study | Experimental | Diagnostic Test: LuViva Advanced Cervical ScanExperimental device being evaluated for sensitivity and specificity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to read or understand and give informed consent
- Referral Pap test within 120 days
- Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.*
Key exclusion criteria (12 listed)
- Pregnancy
- Menstruating on the day of colposcopy and LuViva test
- Radiation therapy to her genitourinary system within 1 year
- Prior hysterectomy in which cervix was removed
- Congenital anatomical cervical variant (e.g., double cervix)
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 |
|---|---|---|
| LuViva Advanced Cervical ScanMultimodal hyperspectral device | Diagnostic test | Singe-arm Study |
Primary outcome
Sensitivity of Diagnostic Device
Time frame: up to 60 days after completion of enrollment
LuViva's ability to correctly identify diseased tissue. LuViva result indicated High-risk and the pathology results indicate the presence of disease cervical tissue.
1 secondary outcome
Specificity of Diagnostic Device
Time frame: up to 60 days after completion of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 11792748Sherman ME, Schiffman M, Cox JT; Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study Group. Effects of age and human papilloma viral load on colposcopy triage: data from the randomized Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS). J Natl Cancer Inst. 2002 Jan 16;94(2):102-7. doi: 10.1093/jnci/94.2.102.
- Background: PubMed 11966387Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ; ASCCP-Sponsored Consensus Conference. 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA. 2002 Apr 24;287(16):2120-9. doi: 10.1001/jama.287.16.2120.
- Background: PubMed 12824967ASCUS-LSIL Traige Study (ALTS) Group. Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance. Am J Obstet Gynecol. 2003 Jun;188(6):1383-92. doi: 10.1067/mob.2003.457.
- Background: PubMed 12798706Massad LS, Collins YC. Strength of correlations between colposcopic impression and biopsy histology. Gynecol Oncol. 2003 Jun;89(3):424-8. doi: 10.1016/s0090-8258(03)00082-9.
- Background: PubMed 9540955Mitchell MF, Schottenfeld D, Tortolero-Luna G, Cantor SB, Richards-Kortum R. Colposcopy for the diagnosis of squamous intraepithelial lesions: a meta-analysis. Obstet Gynecol. 1998 Apr;91(4):626-31. doi: 10.1016/s0029-7844(98)00006-4.
- Background: PubMed 28953109Wentzensen N, Massad LS, Mayeaux EJ Jr, Khan MJ, Waxman AG, Einstein MH, Conageski C, Schiffman MH, Gold MA, Apgar BS, Chelmow D, Choma KK, Darragh TM, Gage JC, Garcia FAR, Guido RS, Jeronimo JA, Liu A, Mathews CA, Mitchell MM, Moscicki AB, Novetsky AP, Papasozomenos T, Perkins RB, Silver MI, Smith KM, Stier EA, Tedeschi CA, Werner CL, Huh WK. Evidence-Based Consensus Recommendations for Colposcopy Practice for Cervical Cancer Prevention in the United States. J Low Genit Tract Dis. 2017 Oct;21(4):216-222. doi: 10.1097/LGT.0000000000000322.
- Background: PubMed 23591399Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.
- Background: PubMed 30694884Huh WK, Papagiannakis E, Gold MA. Observed Colposcopy Practice in US Community-Based Clinics: The Retrospective Control Arm of the IMPROVE-COLPO Study. J Low Genit Tract Dis. 2019 Apr;23(2):110-115. doi: 10.1097/LGT.0000000000000454.
- Background: PubMed 32243307Perkins RB, Guido RS, Castle PE, Chelmow D, Einstein MH, Garcia F, Huh WK, Kim JJ, Moscicki AB, Nayar R, Saraiya M, Sawaya GF, Wentzensen N, Schiffman M; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020 Apr;24(2):102-131. doi: 10.1097/LGT.0000000000000525. No abstract available.
- Background: PubMed 32243306Cheung LC, Egemen D, Chen X, Katki HA, Demarco M, Wiser AL, Perkins RB, Guido RS, Wentzensen N, Schiffman M. 2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation. J Low Genit Tract Dis. 2020 Apr;24(2):90-101. doi: 10.1097/LGT.0000000000000528.
- Background: PubMed 28953112Waxman AG, Conageski C, Silver MI, Tedeschi C, Stier EA, Apgar B, Huh WK, Wentzensen N, Massad LS, Khan MJ, Mayeaux EJ Jr, Einstein MH, Schiffman MH, Guido RS. ASCCP Colposcopy Standards: How Do We Perform Colposcopy? Implications for Establishing Standards. J Low Genit Tract Dis. 2017 Oct;21(4):235-241. doi: 10.1097/LGT.0000000000000336.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuViva Advanced Cervical Scan in people with Cervical Dysplasia, run by Guided Therapeutics at 4 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 4 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity of Diagnostic Device (time frame: up to 60 days after completion of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915495, which also lists 23 linked publications.
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 21 Mar 2025.