Clinical trial · Interventional
Pilot Study for Speculum Free Cervical Cancer Screening
A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
NCT04107181CI-TRIAL-00104926CallarecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interviews only | Behavioral | — | UNRESOLVED |
| Introducer "calla" device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient surveillance
- description
- The introducer will be used during annual Pap smears for cervical cancer screening.
- interventionNames
- Device: Introducer "calla" device
- type
- EXPERIMENTAL
- label
- Healthy Volunteers
- description
- There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix.
- interventionNames
- Behavioral: Interviews only
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Healthy female * Aged 21-65 years * Have had a pelvic exam * Have conversational proficiency in English * Highest level of education attained Exclusion Criteria: \- Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.