N/A
N=130
An Innovative Treatment for Cervical Pre Cancer
Cervical Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT02814448 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy — 6.0; 5.6; 5.3; 5.5 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CryoPen (Device); CO2 standard cryotherapy (Device); Thermocoagulator (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy |
6.0; 5.6; 5.3; 5.5; 3.5 | — |
| SECONDARY Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation |
2.2; 1.8; 2.5; 2.6; 4.1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02814448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.