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NCT06861504 · ClinicalTrials.gov registry record · NA
The Femscope Calm Collect Device
A NA study of Cervical Cancer, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT06861504: Completed NA study of Cervical Cancer, sponsored by University of Michigan.
NCT06861504 is a NA study of Cervical Cancer that has completed, run by University of Michigan. The registered enrollment target is 13 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06861504, a NA study of Cervical Cancer, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Femscope Calm Collect Device
Study Locations (1)
Michigan
- University of Michigan Flint - Flint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2025-08-28 |
| Phase | NA |
What the finished NCT06861504 record still lists
NCT06861504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 1 intervention - of which Femscope Calm Collect Device is the first listed.
NCT06861504 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06861504 about?
NCT06861504 is a clinical study titled "The Femscope Calm Collect Device". 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 ques...
What is the current status of trial NCT06861504?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2024-12-12. Estimated completion is 2025-08-28.
What conditions does trial NCT06861504 study?
This clinical trial studies the following conditions: Cervical Cancer.
What interventions are being tested in trial NCT06861504?
The interventions under investigation include: Femscope Calm Collect Device (DEVICE).
Who is sponsoring clinical trial NCT06861504?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06861504 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06861504's enrollment target sits among peer trials
13 141st of 144 higher than 4 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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