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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
80
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.
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
RECRUITINGRiverview Medical Center
Red Bank, New Jersey, United States
RECRUITINGObservation of the presence of endometrial cells captured by the pad.
Direct observation of the absence or presence of endometrial cells on the pad by the pathologist
Time frame: Within 7 days after receipt of the pad from patients
Association of the presence/absence of cells and morphology
Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant.
Time frame: Within 7 days after receipt of the pad from patients
Patient preferences - Comfort
To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C). Patient preferences regarding comfort of wearing the pad are captured using a 1-3 Likert scale with 1 being not comfortable and 3 being comfortable.
Time frame: Within the same day and after wearing the pad for 4-6 hours
Patient preferences - Simplicity of using the pad
To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C). Patient preferences regarding simplicity of using the pad are captured using a 4 Likert scale with 1 being not easy and 4 being very easy.
Time frame: Within the same day and after wearing the pad for 4-6 hours
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