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The Femscope Calm Collect Device

NCT06861504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-10-27

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if cervical cells collected by the Femscope Calm Collect Device in women (sex assigned at birth) of adult age are the same quality and quantity as the cervical cells collected by the traditional brush method for cervical cancer screening. The main questions it aims to answer are:

1. Increase the number of women who get screened for cervical cancer.
2. Improve patient acceptance of getting cervical screening on a routine basis.
3. Decrease pain and discomfort for patients having a PAP smear procedure.

Participants will

* Have two vaginal exams to collect cervical cells.
* State decreased pain and discomfort for patients having a PAP smear procedure.
* The Femscope Calm Collect Device (FCCD) will be more comfortable for the patient as measured by a patient satisfaction survey comparing the FCCD and the traditional speculum method of obtaining cervical cells.

Conditions

Interventions

DEVICE

Femscope Calm Collect Device

The Femscope Calm Collect Device uses a patented brush for cervical cell collection.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-08-28
Completion
2025-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861504 on ClinicalTrials.gov