Endometrial Cell Collection With the PadKit
- Conditions
- Neoplasms
- Interventions
- Device: PadKit™ from Preprogen
- Registration Number
- NCT06464107
- Lead Sponsor
- Hackensack Meridian Health
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy PadKit™ from Preprogen Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy Benign clinical indications PadKit™ from Preprogen Women with planned hysterectomy for benign clinical indications
- Primary Outcome Measures
Name Time Method Observation of the presence of endometrial cells captured by the pad. Within 7 days after receipt of the pad from patients Direct observation of the absence or presence of endometrial cells on the pad by the pathologist
Association of the presence/absence of cells and morphology Within 7 days after receipt of the pad from patients Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant.
- Secondary Outcome Measures
Name Time Method Patient preferences - Comfort Within the same day and after wearing the pad for 4-6 hours 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.Patient preferences - Simplicity of using the pad Within the same day and after wearing the pad for 4-6 hours 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.
Trial Locations
- Locations (4)
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States