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Trial Title:
Endometrial Cell Collection With the PadKit
NCT ID:
NCT06464107
Condition:
Neoplasms
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
endometrial cancer
endometrial hyperplasia
neoplasms
atypical endometrial hyperplasia
Endometrial cells
interlabial pad
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
PadKit™ from Preprogen
Description:
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.
Arm group label:
Benign clinical indications
Arm group label:
Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
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.
Criteria for eligibility:
Criteria:
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).
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jersey Shore University Medical Center
Address:
City:
Neptune
Zip:
07753
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diane Russomanno
Phone:
732-776-2421
Email:
diane.russomanno@hmhn.org
Facility:
Name:
Riverview Medical Center
Address:
City:
Red Bank
Zip:
07701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diane Russomanno
Phone:
732-776-2421
Email:
diane.russomanno@hmhn.org
Start date:
May 31, 2024
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Hackensack Meridian Health
Agency class:
Other
Collaborator:
Agency:
Preprogen
Agency class:
Other
Source:
Hackensack Meridian Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464107
