NCT06464107

Endometrial Cell Collection With the PadKit

Endometrial Cancer Cell Collection With the Preprogen PadKit™

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2024-06-18
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study