Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.

Participants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection.

Teal Health Self-Collection Device Group

Evaluation of a novel self-collection device for cervical cancer screening.

The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Development of a Self-collection Device for Cervical Cancer Screening

Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening

Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection

Detection of high risk HPV in self-collected as compared to clinician-collected sample results.

Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.

Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)

Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)

Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis

Teal Health, Inc.

Patients with genotype of HR-HPV 16/18 who underwent cervical biopsy with colposcopy

Patients with genotype of HR-HPV non-16/18 who underwent cervical biopsy with colposcopy

high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.

colposcopy and colposcopic biopsy

The only malignancy screening test among gynecological cancers is cervical cancer.

Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive patients undergo colposcopy in the routine screening program.

Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota after 1 year.

the authors performed colposcopy with this study; authors aimed to compare the results of patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find out whether there was any difference between them.

In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier periods by performing colposcopic examination instead of expecting to perform quota after 1 year. we aimed to remove.

Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity

Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity in Normal Women With Cytology

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV 16/18

Results of colposcopies and retrieved colposcopic biopsy of patients with Genotype of HR-HPV non 16/18

Kanuni Sultan Suleyman Training and Research Hospital

principal investigator, M.D, Department of Obstetrics and Gynecology

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.

Teal Wand Self-Collection Device Group

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.

Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).

To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).

Primary Effectiveness Objective

• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:

* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
* Calculating the invalid rate of tested samples.

SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening

PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples

SAE rate is equivalent for both self-collect and clinician collect interventions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of a Self-collection Device for Cervical Cancer Screening	NCT05669911	Human Papilloma... Human Papilloma... Human Papilloma...	Teal Health Sel...	25 Years - 65 Years	Teal Health, Inc.
Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity	NCT03895905	Human Papilloma... Cervical Neopla...	colposcopy and ...	20 Years - 65 Years	Kanuni Sultan Suleyman Training and Research Hospital
Development of a Self-collection Device for Cervical Cancer Screening	NCT05669911	Human Papilloma... Human Papilloma... Human Papilloma...	Teal Health Sel...	25 Years - 65 Years	Teal Health, Inc.
Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity	NCT03895905	Human Papilloma... Cervical Neopla...	colposcopy and ...	20 Years - 65 Years	Kanuni Sultan Suleyman Training and Research Hospital
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening	NCT06120205	Hpv HPV 16 Infectio... HPV Infection High Risk HPV	Teal Wand Self-...	25 Years - 65 Years	Teal Health, Inc.

Spots Global Cancer Trial Database for high risk hpv