Clinical trial · Interventional
Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
NCT03750214CI-TRIAL-00042796unknownN/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)
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
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 Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biop Colposcopy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biop Coplposcopy System
- description
- Biop Colposcopy system procedure
- interventionNames
- Device: Biop Colposcopy System
Primary outcomes (2)
- measure
- Performance
- timeFrame
- procedure day ± 1 day
- description
- The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.
- measure
- frequency and incidence of all Adverse Events
- timeFrame
- procedure day ± 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Females, ages 22 to 65 years old * Referred for colposcopy, following abnormal cervical cytology * Subject provides signed informed consent Exclusion Criteria: * Currently pregnant or nursing * Currently menstruating * Currently has intrauterine device (IUD) * Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera. * Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system * HIV-positive status * Psychological instability, inappropriate attitude or motivation * Use of any additional experimental drug or device or participation in another clinical study within the past 30 days
References
Publications (0)
Data not yet available
No reference posted for this study.