Clinical trial · Interventional
Biop System's Safety and Performance
Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy
NCT04232865CI-TRIAL-00042810unknownN/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)
Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biop System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bןםפ Sטדאקצ
- description
- Biop Colposcopy procedure
- interventionNames
- Device: Biop System
Primary outcomes (2)
- measure
- SAE
- timeFrame
- through study completion, an average of 1 year
- description
- The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
- measure
- Performance
- timeFrame
- through study completion, an average of 1 year
- description
- Incremental True positive (TP) rate and Incremental False positive (FP) rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female Age ≥ 22 years and ≤ 65. * Referred for colposcopy, following abnormal cervical cytology; * Participant provides signed informed consent Exclusion Criteria: * Currently pregnant (through six weeks postpartum) or nursing * Currently menstruating * Previous hysterectomy * Currently has intrauterine device (IUD) * Cervical biopsy or therapeutic procedure since the referral cervical cytology, * Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera. * Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) (Applicable to training stage only) * A known latex allergy * Psychological instability, inappropriate attitude or motivation * Cervical cytology tests within the prior seven days * Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h * History of photosensitivity or other diseases affected by UV radiation, * An observable and untreated gynecological infection. * Previous history of CIN therapy
References
Publications (0)
Data not yet available
No reference posted for this study.