NCT06861504

Brief 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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

January 10, 2025

Last Update Submit

October 23, 2025

Conditions

Cervical Cancer

Keywords

Cervical cancer screening

Outcome Measures

Primary Outcomes (3)

  • Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method

    Specimen adequacy will be assessed using the Bethesda System For Reporting Cervical Cytology. Specimens will be rated as Satisfactory or Unsatisfactory for evaluation. The presence/absence of a Endocervical/Transformation Zone (EC/TZ) component, partially obscuring blood, and inflammation are indicators the Pap test is satisfactory for evaluation.

    1 hour

  • Number of Participants Who Experienced Pain/Discomfort During The Femscope Calm Collect Procedure

    A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the Femscope Calm Collect Procedure.

    Immediately post-procedure

  • Number of Participants Who Experienced Pain/Discomfort During The Regular Pap Procedure

    A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the regular Pap procedure

    Immediately post-procedure

Study Arms (1)

Cervical cell collection of traditional brush and Femscope Calm Collect Device

EXPERIMENTAL

Cervical cells of the Femscope Calm Collect Device will be evaluated by a board-certified pathologist to determine if the quality and quantity of cells are equivalent to the traditional brush collection.

Device: Femscope Calm Collect Device

Interventions

Femscope Calm Collect DeviceDEVICE

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

Cervical cell collection of traditional brush and Femscope Calm Collect Device

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants must have female sexual organs present at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy female ages 21-45 with female reproductive organs present at the time of study.

You may not qualify if:

  • Pregnancy
  • Menopausal
  • Age less than 21 years
  • Age of 46+ years
  • History of reproductive cancer
  • Hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Flint

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All specimens collected will receive a randomized number so the pathologist is not aware of the samples collected by the traditional brush method (Pap smear) and the cells collected by the Femscope Calm Collect Device.
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: The Femscope Calm Collect Device will be used to collect a sample of cervical cells that a board-certified pathologist will read.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing, School of Nursing, The University of Michigan-Flint

Study Record Dates

First Submitted

January 10, 2025

First Posted

March 6, 2025

Study Start

December 12, 2024

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Will need to determine if Femscope Calm Collect Device meets cervical cell collection criteria.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
1/1/2026
Access Criteria
Research team

Locations

US(1)