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

NAActive, not recruitingINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

November 20, 2023

Primary Completion Date

April 5, 2024

Study Completion Date

June 1, 2027

Conditions
HpvHPV 16 InfectionHPV InfectionHigh Risk HPV
Interventions
DEVICE

Teal Wand Self-Collection Device Group

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.

Trial Locations (15)

11501

New York University Langone Hospital, Mineola

21287

Johns Hopkins University, Baltimore

27103

Unified Women's Clinical Research - Lyndhurst, Winston-Salem

27607

Unified Women's Clinical Research Raleigh, Raleigh

35235

Birmingham OBGYN / Alabama Clinical Therapeutics, Birmingham

53715

University of Wisconsin - Madison, Madison

62208

Planned Parenthood St. Louis Region, St Louis

63110

Washington University, St Louis

70817

Woman's Hospital, Baton Rouge

77023

Planned Parenthood Gulf Coast, Houston

80045

University of Colorado Anschutz Medical Campus, Aurora

94109

Planned Parenthood Northern California, San Francisco

06511

Planned Parenthood Southern New England, New Haven

06520

Yale University, New Haven

02215

Planned Parenthood League of Massachusetts, Boston

All Listed Sponsors
lead

Teal Health, Inc.

INDUSTRY

NCT06120205 - SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening | Biotech Hunter | Biotech Hunter