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LuViva Advanced Cervical Scan for Cervical Dysplasia
N/A
Waitlist Available
Research Sponsored by Guided Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days after completion of enrollment
Awards & highlights
Study Summary
This trial shows a new device can help detect cervical disease better by separating low and high risk women for enhanced testing.
Who is the study for?
This trial is for women who can consent, have had a Pap test within the last 120 days, and are scheduled for colposcopy based on certain risk guidelines. It's not for those who are pregnant, have had radiation therapy to the pelvic area in the past year, lack a cervix due to hysterectomy, or have conditions that could interfere with testing.Check my eligibility
What is being tested?
The study tests if the LuViva Advanced Cervical Scan can accurately categorize women into low or high risk of cervical disease after abnormal screening results. This may help decide if they need more thorough exams and biopsies to detect serious cervical changes.See study design
What are the potential side effects?
The description does not specify side effects related to the LuViva scan; however, as it is a non-invasive hyperspectral scanning device, risks may be minimal compared to invasive procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days after completion of enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days after completion of enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity of Diagnostic Device
Secondary outcome measures
Specificity of Diagnostic Device
Trial Design
1Treatment groups
Experimental Treatment
Group I: Singe-arm StudyExperimental Treatment1 Intervention
Experimental device being evaluated for sensitivity and specificity.
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Who is running the clinical trial?
Guided TherapeuticsLead Sponsor
2 Previous Clinical Trials
2,399 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation therapy to my urinary or genital organs in the last year.I am scheduled for a colposcopy due to a moderate risk of severe cervical changes.My cervix is easily irritated or bleeds.I have had a hysterectomy with my cervix removed.I am menstruating on the day of my scheduled colposcopy and LuViva test.I am currently receiving phototherapy treatment.I have recently used medications that increase sensitivity to light.I have a condition that worsens with sunlight exposure.I experience bleeding after sex or significant bleeding recently.
Research Study Groups:
This trial has the following groups:- Group 1: Singe-arm Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment actively seeking participants at the moment?
"As per the clinicaltrials.gov, this medical trial is not accepting participants at present. It was first announced on April 1st 2023 and has most recently been updated February 27th of the same year. Fortunately, 47 other trials are currently open to new enrollment."
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