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Completed

NCT Number: NCT06464107

Endometrial Cell Collection With the 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.

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Key information

Conditions

Neoplasms Endometrial Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jersey Shore University Medical Center, Neptune City, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.
  • Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
  • Cohort 2: women with planned hysterectomy for benign clinical indications

Exclusion criteria

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

Treatment and study plan

PadKit™ from Preprogen

Device

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Preprogen

Registry information

Official study title

Endometrial Cancer Cell Collection With the Preprogen PadKit™

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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