Clinical trial · Observational
IMproved PRactice Outcomes and Value Excellence in Colposcopy
NCT02185599CI-TRIAL-00044002IMPROVE-COLPOcompletedClinicalTrials.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 study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan. The study will collect colposcopy data across multiple sites in two arms; a prospective arm, with DySIS being used for the examination and a retrospective arm, with data retrieved from patient charts.
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 |
|---|---|---|---|
| High Grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DySIS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Colposcopy with DySIS
- description
- The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
- interventionNames
- Device: DySIS
- label
- Standard colposcopy
- description
- The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.
Primary outcomes (1)
- measure
- Number of subjects diagnosed with CIN2+ cervical lesions
- timeFrame
- At time of colposcopy
- description
- Changes in number of subjects diagnosed with CIN2+ cervical lesions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females 21 years or older 2. Able to give informed consent 3. Referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice: * HSIL, ASC-H, LSIL cytology * 2x ASC-US cytology (25 or above) * 2x/3x LSIL/ASC-US cytology (21-24) * ASC-US pap and hrHPV cotest/reflex * HPV 16/18 primary screening (≥25) * ASC-US pap after hrHPV * hrHPV x2 (≥30) * HPV16 or 16 after negative cytology/hrHPV (≥30) * Follow-up of CIN2/3 biopsy (younger women) * hrHPV and/or ≥ASC-US pap post-excision Exclusion Criteria: 1. Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer 2. Pregnancy 3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) 4. Referred for vulva/vaginal disease
References
Publications (0)
Data not yet available
No reference posted for this study.