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Endometrial Cell Collection With the PadKit
Sponsor: Hackensack Meridian Health
Summary
All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium. After the kit is returned to the Preprogen laboratory, a brief survey will be completed. Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.
Official title: Endometrial Cancer Cell Collection With the Preprogen PadKit™
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-05-31
Completion Date
2026-05-30
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
PadKit™ from Preprogen
The interlabial pad is classified as a Class 1 device by the FDA and the device is exempt from requiring a 510(k) approval. The interlabial pad is worn for 4-6 consecutive hours and collects cells shed from the cervix and uterine cavity. The pad is then removed and placed in the smaller, inner tube that contains the transport solution. After replacing the lid securely, it is then carefully placed back inside the larger outer tube with the outer lid secured and returned to the original box. The entire box is placed in the polybag and mailed back to the lab for analysis.
Locations (2)
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Riverview Medical Center
Red Bank, New Jersey, United States