Clinical trial · Interventional
An Innovative Treatment for Cervical Pre Cancer
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
NCT02814448CI-TRIAL-00035891CryoPencompletedN/AResults postedClinicalTrials.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 purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.
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 Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO2 standard cryotherapy | Device | — | UNRESOLVED |
| CryoPen | Device | — | UNRESOLVED |
| Thermocoagulator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- CO2 standard cryotherapy- double freeze
- description
- Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
- interventionNames
- Device: CO2 standard cryotherapy
- type
- ACTIVE_COMPARATOR
- label
- CO2 standard cryotherapy- single freeze
- description
- Single freeze treatment consists of one five-minute freeze
- interventionNames
- Device: CO2 standard cryotherapy
- type
- ACTIVE_COMPARATOR
- label
- CryoPen- double freeze
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Between 25 and 65 years old. * Scheduled for a hysterectomy for reasons other than cervical precancer or cancer * Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted * Histological evaluation of the cervix does not interfere with the woman's current diagnosis * Woman consents to participate after being informed about the study * Normal Pap Smear or HPV test in the past 3 years Exclusion Criteria: * Pregnancy * History of cervical surgery in past 5 years * Presence of cervical lesion pre-invasive or invasive on the cervix \* * Current Pelvic Inflammatory Disorder or severe acute cervicitis * Cervix shape disfigured or hard to reach
References
Publications (0)
Data not yet available
No reference posted for this study.