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Could a simple pad replace invasive biopsies for uterine cancer?

NCT ID NCT06464107

Diagnosis Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special pad (PadKit™) worn for 4-6 hours to collect cells shed from the uterus. Researchers wanted to see if the pad could gather enough cells to tell the difference between normal tissue, precancerous changes, and cancer. 80 women scheduled for surgery (some with cancer or precancer, some with benign conditions) wore the pad before their procedure. The goal is to find a less invasive way to screen for endometrial cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PadKit™ (interlabial pad device)
What this could lead to
If successful, this pad could offer a simple, at-home way to screen for endometrial cancer or abnormal cell growth, reducing the need for invasive procedures.
What could go wrong
This is a small, completed feasibility study (80 participants) that only checks if the pad can collect enough cells. It does not prove the pad can reliably diagnose cancer, and results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

May 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

endometrial cancer Endometrial Hyperplasia endometrium neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms

Contacts and locations

Locations

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Riverview Medical Center

    Red Bank, New Jersey, 07701, United States

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