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Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy
Biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy.
This is a multi-center, prospective, open label, non-randomized study to train the Biop System's algorithm and evaluate the safety and performance of the Biop system in women undergoing cervical colposcopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bןםפ Sטדאקצ | Experimental | Biop Colposcopy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biop System | Device | Stage 1 - Training: Up to 320 women in whom a complete procedure with the Biop System will be performed. Biopsies will be taken solely based on colposcopy examination. Enrolled participants will include at least 80 participants Histopathology identified with a high-grade lesion and at least 80 participants Histopathology identified as normal or with a low-grade lesion. Stage 2 - Validation: Up to 330 HIV negative women in whom a complete procedure with the Biop System will be performed. Validation stage will also include up to 165 HIV positive participants. All participants will be enrolled in up to 3 sites in South Africa. |
| Measure | Description | Time Frame |
|---|---|---|
| SAE | The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE). | through study completion, an average of 1 year |
| Performance | Incremental True positive (TP) rate and Incremental False positive (FP) rate | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |