Endometrial Cell Collection With the PadKit

May 12, 2026 updated by: Hackensack Meridian Health

Endometrial Cancer Cell Collection With the Preprogen PadKit™

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.

  1. Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
  2. Cohort 2: women with planned hysterectomy for benign clinical indications

Exclusion criteria

  1. Unable to provide informed consent
  2. Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Device: 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.
Experimental: Benign clinical indications
Women with planned hysterectomy for benign clinical indications
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of the presence of endometrial cells captured by the pad.
Time Frame: 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
Within 7 days after receipt of the pad from patients
Association of the presence/absence of cells and morphology
Time Frame: 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.
Within 7 days after receipt of the pad from patients

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preferences - Comfort
Time Frame: 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.
Within the same day and after wearing the pad for 4-6 hours
Patient preferences - Simplicity of using the pad
Time Frame: 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.
Within the same day and after wearing the pad for 4-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

Preprogen

Investigators

  • Principal Investigator: Mark G Borowsky, MD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Actual)

April 17, 2026

Study Completion (Actual)

April 17, 2026

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2023-0428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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